FDA Device recall Z-1921-2014
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914
- FDA Device
- Class I
- terminated
- Published 2014-07-09
On 2014-07-09 the FDA classified a Class I recall of Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914 by Medtronic Neurosurgery, citing medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring System….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1921-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-06-09 |
| Published | 2014-07-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | PR |
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
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.
Identifiers
| code_info | Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741…Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1921-2014%22
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