FDA Device recall Z-1163-2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, 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, REF 46914, 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-1163-2024 |
| 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, REF 46914, 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: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971…Lot Number/GTIN: 221482529 00763000395971; 221520718 00763000395971; 221648854 00763000395971; 221687765 00763000395971; 221744158 00763000395971; 221744549 00763000395971; 221795479 00613994445377; 221827827 00613994445377; 221827828 00613994445377; 221873427 00763000395971; 221873428 00763000395971; 221915124 00763000395971; 221915125 00763000395971; 221916163 00613994445377; 221916164 00763000395971; 221955230 00763000395971; 221955231 00763000395971; 222015665 00613994445377; 222061755 00613994445377; 222204094 00613994445377; 222345104 00613994445377; 222345105 00613994445377; 222346067 00613994445377; 222393929 00763000395971; 222393930 00763000395971; 222530273 00613994445377; 222543362 00763000395971; 222543363 00763000395971; 222580924 00613994445377; 222970856 00613994445377; 222970857 00613994445377; 222970858 00613994445377; 222999295 00613994445377; 222999296 00613994445377; 223070846 00763000395971; 223130156 00763000395971; 223165960 00763000395971; 223165961 00763000395 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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-1163-2024%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.