FDA Device recall Z-0873-2021
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass…
- FDA Device
- Class II
- ongoing
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Ass… by Medtronic Neurosurgery, citing neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0873-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-16 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
Product
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.
Reason
Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction
Identifiers
| code_info | Lot # 0219948893, 0220166870, 0220236215, 0220704352, 0220720015, 0220752505 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Medtronic Neurosurgery
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FDA Device · Class II · 2026-07-29 · Medtronic Neurosurgery - Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040…
FDA Device · Class I · 2024-12-25 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery - Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only
FDA Device · Class I · 2024-03-06 · Medtronic Neurosurgery
All Medtronic Neurosurgery recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0873-2021%22
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