Medtronic Duet External Drainage and Monitoring System — Class I medical device recall Z-1163-2024
Ongoing recall by Medtronic Neurosurgery, reported 2024-03-06, distributed nationwide. Potential for catheter disconnection from the patient line stopcock connectors.
| Recall number | Z-1163-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Irvine, CA, United States |
| Recall initiated | 2024-01-22 |
| Classified | 2024-02-27 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BE, BG, BH, CA, CH, CL, CN, CO, CR, CW, DE, DK, DO, EC, ES, FI, GB, GH, GR, HK, HR, IE, IR, IS, IT, KW, LV, MT, MX, MY, NI, NL, NO, PA, PE, PH, PK, PL, PT, QA, RO, SA, SE, SG, SV, TR, VN, ZA |
| Quantity | 32,404 units |
| UPC / GTIN / UDI-DI | 00613994445377, 00763000395971, 00763000624774 |
| Model numbers | 46914 |
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 for recall
Potential for catheter disconnection from the patient line stopcock connectors.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1163-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.