FDA Device recall Z-1162-2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, 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, REF 46913, 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-1162-2024 |
| 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, REF 46913, 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: 221482527 00613994445360; 221569956 00763000406004; 221569957 00763000406004; 221614450 00613994445360…Lot Number/GTIN: 221482527 00613994445360; 221569956 00763000406004; 221569957 00763000406004; 221614450 00613994445360; 221614451 00613994445360; 221614452 00613994445360; 221687764 00763000406004; 221744157 00763000406004; 221744547 00763000406004; 221795478 00613994445360; 221873430 00763000406004; 221955228 00763000406004; 221955229 00763000406004; 222061753 00763000406004; 222061754 00763000406004; 222082061 00613994445360; 222121358 00613994445360; 222186493 00613994445360; 222186494 00613994445360; 222186495 00613994445360; 222240558 00613994445360; 222240559 00613994445360; 222240560 00613994445360; 222274124 00613994445360; 222274125 00613994445360 222322811 00763000406004; 222322812 00763000406004; 222322813 00763000406004; 222580925 00763000406004; 223564705 00763000624767; 223659557 00763000624767; 223659558 00763000624767;; 223734520 00763000624767; 223778508 00763000624767; 223818450 00763000624767; 223999039 00763000406004; 224032596 00763000406004; 224197127 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-1162-2024%22
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