| 2025-09-25 |
Class II
|
Ongoing |
Z-0486-2026 |
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06… |
— |
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for un… |
| 2025-09-25 |
Class II
|
Ongoing |
Z-0485-2026 |
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT; |
— |
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for un… |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0257-2025 |
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-… |
— |
Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. |
| 2024-04-15 |
Class II
|
Ongoing |
Z-1891-2024 |
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surg… |
— |
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery |
| 2024-03-15 |
Class II
|
Ongoing |
Z-1635-2024 |
Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaT… |
— |
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating |
| 2024-03-15 |
Class II
|
Ongoing |
Z-1634-2024 |
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Sil… |
— |
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1471-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1470-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1469-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1468-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1467-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1466-2024 |
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1465-2024 |
Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB |
— |
The potential for trocar seal disengagement when using mesh products incorrectly with the device. |
| 2024-02-14 |
Class II
|
Ongoing |
Z-1458-2024 |
Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT |
— |
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is rela… |
| 2024-02-14 |
Class II
|
Ongoing |
Z-1457-2024 |
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT |
— |
Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is rela… |
| 2024-01-25 |
Class II
|
Ongoing |
Z-1697-2024 |
Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of … |
— |
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutur… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0845-2024 |
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK… |
— |
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over… |
| 2023-12-21 |
Class II
|
Ongoing |
Z-0844-2024 |
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 888… |
— |
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over… |
| 2023-11-16 |
Class II
|
Ongoing |
Z-0986-2024 |
AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material t… |
— |
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromisin… |
| 2023-08-22 |
Class II
|
Ongoing |
Z-2632-2023 |
Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm |
— |
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable ba… |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2391-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 88883… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2390-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2389-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2388-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2387-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2386-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2385-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 88… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2384-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2383-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2382-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2381-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2380-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2379-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2378-2023 |
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629 |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2377-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2376-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2375-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 888810300… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2374-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 888810300… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2373-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 888810300… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2372-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2372-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2371-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 888810200… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2370-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004H… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2369-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003H… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2368-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002H… |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-06-28 |
Class I
|
Ongoing |
Z-2367-2023 |
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP |
— |
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which … |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1465-2023 |
VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STS |
— |
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where t… |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1464-2023 |
VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STS |
— |
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where t… |
| 2023-03-22 |
Class II
|
Ongoing |
Z-1463-2023 |
VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STS |
— |
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where t… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1390-2023 |
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2) |
— |
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product m… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1389-2023 |
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K) |
— |
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product m… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1388-2023 |
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMI… |
— |
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product m… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1387-2023 |
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number … |
— |
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product m… |
| 2023-01-25 |
Class II
|
Ongoing |
Z-1228-2023 |
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT |
— |
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue… |
| 2023-01-11 |
Class II
|
Ongoing |
Z-1183-2023 |
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended fo… |
— |
Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions, erosion/migration, pain, fistula, hernia (recurrence)… |
| 2022-12-07 |
Class I
|
Ongoing |
Z-0877-2023 |
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensi… |
— |
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fl… |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1182-2023 |
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1181-2023 |
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICR… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1180-2023 |
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P … |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1179-2023 |
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1178-2023 |
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1177-2023 |
Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1176-2023 |
Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SO… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1175-2023 |
Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOV… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1174-2023 |
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSO… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1173-2023 |
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 1… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-12-02 |
Class II
|
Ongoing |
Z-1172-2023 |
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM… |
— |
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0201-2023 |
Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VL… |
— |
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for… |
| 2022-09-28 |
Class II
|
Ongoing |
Z-0200-2023 |
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA3… |
— |
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for… |
| 2022-05-13 |
Class II
|
Ongoing |
Z-1322-2022 |
EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535. |
— |
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage an… |
| 2021-12-22 |
Class II
|
Ongoing |
Z-0514-2022 |
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT) |
— |
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect dur… |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2375-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2374-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2373-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2372-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2371-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2370-2021 |
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888… |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2369-2021 |
Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2368-2021 |
Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2367-2021 |
Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2366-2021 |
Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2365-2021 |
Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2364-2021 |
Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2363-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 55cm, Item Code 8888541055 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2362-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 44cm, Item Code 8888541044 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2361-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33cm, Item Code 8888541033 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2360-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 28 cm, Item Code 8888541028 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2359-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 23 cm, Item Code 8888541023 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-05-28 |
Class II
|
Ongoing |
Z-2358-2021 |
Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019 |
— |
This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| 2021-04-29 |
Class II
|
Ongoing |
Z-1869-2021 |
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients… |
— |
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene… |
| 2021-04-29 |
Class II
|
Ongoing |
Z-1868-2021 |
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized … |
— |
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene… |
| 2021-04-29 |
Class II
|
Ongoing |
Z-1867-2021 |
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on an… |
— |
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene… |
| 2021-04-29 |
Class II
|
Ongoing |
Z-1866-2021 |
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and … |
— |
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene… |
| 2021-03-04 |
Class II
|
Terminated |
Z-1385-2021 |
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT |
— |
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the s… |
| 2021-03-04 |
Class II
|
Terminated |
Z-1384-2021 |
Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV |
— |
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the s… |
| 2021-03-04 |
Class II
|
Terminated |
Z-1383-2021 |
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT |
— |
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the s… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0009-2021 |
Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - P… |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0008-2021 |
Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA … |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0007-2021 |
Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have app… |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0006-2021 |
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA … |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0005-2021 |
Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal sta… |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0004-2021 |
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA … |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0003-2021 |
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA … |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0002-2021 |
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA … |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |
| 2020-08-12 |
Class II
|
Ongoing |
Z-0001-2021 |
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo… |
— |
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete st… |