| 2026-06-02 |
Class II
|
Ongoing |
Z-2741-2026 |
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use… |
— |
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization r… |
| 2025-08-15 |
Class II
|
Ongoing |
Z-2588-2025 |
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. |
— |
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of … |
| 2025-08-15 |
Class II
|
Ongoing |
Z-2587-2025 |
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. |
— |
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of … |
| 2025-08-15 |
Class II
|
Ongoing |
Z-2586-2025 |
Heartstring III Proximal Seal System. Intravascular anastomosis occluder. |
— |
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of … |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2636-2025 |
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel H… |
— |
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool… |
| 2025-03-20 |
Class II
|
Ongoing |
Z-1622-2025 |
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len… |
— |
There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the … |
| 2025-03-10 |
Class II
|
Ongoing |
Z-1577-2025 |
Maquet VH-3010 Power Supply. Used to deliver power to the harvesting tool of the Vasoview Hemopro EVH System (HemoPro 2)… |
— |
Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. |
| 2024-12-09 |
Class I
|
Ongoing |
Z-0712-2025 |
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in min… |
— |
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| 2024-12-09 |
Class I
|
Ongoing |
Z-0711-2025 |
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive… |
— |
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0486-2025 |
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z |
— |
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2… |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0485-2025 |
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z |
— |
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2… |
| 2024-10-16 |
Class II
|
Ongoing |
Z-0484-2025 |
Acrobat-i Positioner. Model Number C-XP-5000Z |
— |
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2… |
| 2024-09-20 |
Class I
|
Ongoing |
Z-0092-2025 |
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 |
— |
There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2338-2024 |
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Len… |
— |
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to ins… |
| 2024-05-31 |
Class II
|
Ongoing |
Z-2337-2024 |
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng… |
— |
There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to ins… |
| 2024-05-17 |
Class II
|
Ongoing |
Z-2176-2024 |
The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for use in conjunction with the 7 mm Extended Len… |
— |
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when n… |
| 2024-05-17 |
Class II
|
Ongoing |
Z-2175-2024 |
The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System, labeled as the following: 1. VasoView Hemopro 2, Model Numb… |
— |
Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when n… |
| 2023-12-13 |
Class I
|
Ongoing |
Z-0710-2024 |
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit |
— |
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be… |
| 2023-12-13 |
Class I
|
Ongoing |
Z-0709-2024 |
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection |
— |
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0724-2024 |
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500. |
— |
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being intr… |
| 2023-12-01 |
Class II
|
Ongoing |
Z-0723-2024 |
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . |
— |
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being intr… |
| 2023-10-31 |
Class II
|
Ongoing |
Z-0589-2024 |
Acrobat-i Vacuum Positioner System, Model Number XP-5000Z |
— |
The Positioner Arm may not tighten or lock during normal use. |
| 2023-09-19 |
Class II
|
Ongoing |
Z-0210-2024 |
Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, o… |
— |
Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device. |
| 2023-09-13 |
Class II
|
Ongoing |
Z-0137-2024 |
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a s… |
— |
Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previous… |
| 2023-06-28 |
Class II
|
Ongoing |
Z-2274-2023 |
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and ch… |
— |
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab… |
| 2023-06-28 |
Class II
|
Ongoing |
Z-2273-2023 |
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and ches… |
— |
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab… |
| 2023-06-28 |
Class II
|
Ongoing |
Z-2272-2023 |
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and c… |
— |
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab… |
| 2023-06-28 |
Class II
|
Ongoing |
Z-2271-2023 |
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest… |
— |
The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stab… |
| 2023-03-06 |
Class II
|
Ongoing |
Z-1337-2023 |
VASOVIEW HEMOPRO, OUS, Endoscopic Vessel Harvesting System, Model Number C-VH-3000-W |
— |
Some batches of product were not sterilized to their minimum sterilization specification. |
| 2023-03-06 |
Class II
|
Ongoing |
Z-1336-2023 |
VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, Model Number C-VH-4000 |
— |
Some batches of product were not sterilized to their minimum sterilization specification. |
| 2023-03-06 |
Class II
|
Ongoing |
Z-1335-2023 |
VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, Model Number C-VH-3500 |
— |
Some batches of product were not sterilized to their minimum sterilization specification. |
| 2023-01-30 |
Class II
|
Ongoing |
Z-1245-2023 |
Fusion Bioline Vascular Graft, Part number M00201503046B0 |
— |
One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to cust… |
| 2022-12-22 |
Class II
|
Ongoing |
Z-0996-2023 |
Vasoshield Syringe Packs, Model VH-5001 |
— |
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, … |
| 2022-12-22 |
Class II
|
Ongoing |
Z-0995-2023 |
Hemopro 2 with Vasoshield, Model VH-4001 |
— |
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, … |
| 2022-04-29 |
Class II
|
Terminated |
Z-1282-2022 |
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surfa… |
— |
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L:… |
| 2022-02-09 |
Class II
|
Ongoing |
Z-0887-2022 |
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001. |
— |
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed … |
| 2022-01-14 |
Class II
|
Terminated |
Z-0729-2022 |
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement … |
— |
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile pa… |
| 2021-12-01 |
Class II
|
Terminated |
Z-0403-2022 |
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890 |
— |
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M0020… |
| 2020-04-07 |
Class II
|
Terminated |
Z-1882-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1881-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1880-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1879-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175924P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1878-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1877-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1876-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1875-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1874-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1873-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175830P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1872-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1871-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1870-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1869-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175822P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1868-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1867-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use … |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1866-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use i… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1865-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: f… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1864-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: f… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1863-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: f… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1862-2020 |
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: f… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1861-2020 |
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Us… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1860-2020 |
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Us… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |
| 2020-04-07 |
Class II
|
Terminated |
Z-1859-2020 |
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Us… |
— |
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts |