Medtronic Duet External Drainage and Monitoring System — Class I medical device recall Z-1921-2014
Terminated recall by Medtronic Neurosurgery, reported 2014-07-09, distributed in PR. Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the pa
| Recall number | Z-1921-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Goleta, CA, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2014-06-27 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-01-14 |
| Distributed | PR |
| Countries outside the US | AU, BE, CA, CH, CY, DK, EG, FI, FR, GB, GR, HR, IL, IR, IT, KW, NL, NO, PL, RO, SA, SG, TR, ZA |
| Quantity | 5,744 units |
| Lot numbers | 206843112, 206854300, 206875578, 206923218, 206951123, 206962974, 206986677, 207167084, 207246210, 207312741, 207441171, 207466011, 207466012, 207560684, 207632971, 207659577, 207716835, 207716836, 207766493, 207900255, 207945036, 207983301, 208008802 |
| Model numbers | 46914 |
Product
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Reason for recall
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
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-1921-2014. 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.