FDA Device recall Z-1165-2024
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, 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, SmartSite Injection Sites, Ventricular Catheter, REF 46916, 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-1165-2024 |
| 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, SmartSite Injection Sites, Ventricular Catheter, REF 46916, 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: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011…Lot Number/GTIN: 221343119 00613994445391; 221612695 00613994445391; 221873429 00613994445391; 221873431 00763000406011; 222082062 00613994445391; 222480771 00763000406011; 222480772 00763000406011; 223565026 00763000624798; 223580361 00763000624798; 223580378 00763000624798; 223618474 00763000624798; 223621056 00763000624798; 223659561 00763000624798; 223907224 00613994445391; 223907225 00613994445391; 223956150 00613994445391; 223999042 00613994445391; 223999043 00613994445391; 224032609 00613994445391; 224128508 00763000406011; 224387126 00763000406011; 224852795 00613994445391; 224852796 00613994445391; 224878536 00613994445391; 224949834 00613994445391; 224949835 00613994445391; 224990657 00763000624798; 224990660 00613994445391; 224990846 00613994445391; 224990847 00763000624798; 224990889 00763000624798; 225198821 00613994445391; 225500036 00613994445391; 225500037 00613994445391; 225675930 00763000406011; 225675932 00613994445391; 225686835 00613994445391; 225749841 00763000406 |
|---|
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-1165-2024%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.