| 2026-06-17 |
Class II
|
Ongoing |
Z-2768-2026 |
Ventriculostomy Kit, REF: 46154 |
— |
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptabl… |
| 2024-11-01 |
Class I
|
Ongoing |
Z-0662-2025 |
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAID… |
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Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-11-01 |
Class I
|
Ongoing |
Z-0661-2025 |
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY V… |
— |
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-01-22 |
Class I
|
Ongoing |
Z-1166-2024 |
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E… |
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Potential for catheter disconnection from the patient line stopcock connectors. |
| 2024-01-22 |
Class I
|
Ongoing |
Z-1165-2024 |
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Ster… |
— |
Potential for catheter disconnection from the patient line stopcock connectors. |
| 2024-01-22 |
Class I
|
Ongoing |
Z-1164-2024 |
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Ster… |
— |
Potential for catheter disconnection from the patient line stopcock connectors. |
| 2024-01-22 |
Class I
|
Ongoing |
Z-1163-2024 |
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used… |
— |
Potential for catheter disconnection from the patient line stopcock connectors. |
| 2024-01-22 |
Class I
|
Ongoing |
Z-1162-2024 |
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used … |
— |
Potential for catheter disconnection from the patient line stopcock connectors. |
| 2023-06-28 |
Class II
|
Ongoing |
Z-2412-2023 |
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERI… |
— |
Product labeling contains incorrect expiration date |
| 2023-06-13 |
Class II
|
Ongoing |
Z-2207-2023 |
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUR… |
— |
Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present cl… |
| 2021-01-11 |
Class II
|
Ongoing |
Z-1117-2021 |
Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L … |
— |
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of … |
| 2021-01-11 |
Class II
|
Ongoing |
Z-1116-2021 |
Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: … |
— |
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of … |
| 2021-01-11 |
Class II
|
Ongoing |
Z-1115-2021 |
Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24… |
— |
Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of … |
| 2020-12-16 |
Class II
|
Ongoing |
Z-0873-2021 |
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal … |
— |
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securi… |
| 2020-12-16 |
Class II
|
Ongoing |
Z-0872-2021 |
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal … |
— |
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securi… |
| 2020-12-16 |
Class II
|
Ongoing |
Z-0871-2021 |
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal … |
— |
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securi… |
| 2020-12-08 |
Class II
|
Ongoing |
Z-0740-2021 |
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as… |
— |
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase… |
| 2020-12-08 |
Class II
|
Ongoing |
Z-0739-2021 |
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus … |
— |
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase… |
| 2020-12-08 |
Class II
|
Ongoing |
Z-0738-2021 |
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus… |
— |
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase… |