FDA Device recall Z-1164-2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only by Medtronic Neurosurgery, citing potential for catheter disconnection from the patient line stopcock connectors.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1164-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-01-22 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
Product
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
Reason
Potential for catheter disconnection from the patient line stopcock connectors.
Identifiers
| code_info | Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384…Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384; 222163140 00613994445384 222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384; 222439029 00613994445384 222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384; 222817387 00613994445384 223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1164-2024%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.