FDA Device recall Z-0398-2014
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201 by Medtronic Neurosurgery, citing medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0398-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-18 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
Product
Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.
Reason
Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.
Identifiers
| code_info | Lot Numbers: D01859; D11969; D15985; D25462; D37523; D42401. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Medtronic Neurosurgery
- Ventriculostomy Kit, REF: 46154
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-0398-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.