Reported Mar 6, 2024 · Ongoing
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916,…
Medtronic Neurosurgery
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 5290 California Ave · Irvine, CA · 92617-3073
Is this the product you have?
- Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Lot codes and dates
- Lot Number/GTIN
67 of 67 codes
221343119 00613994445391221612695 00613994445391221873429 00613994445391221873431 00763000406011222082062 00613994445391222480771 00763000406011222480772 00763000406011223565026 00763000624798223580361 00763000624798223580378 00763000624798223618474 00763000624798223621056 00763000624798223659561 00763000624798223907224 00613994445391223907225 00613994445391223956150 00613994445391223999042 00613994445391223999043 00613994445391224032609 00613994445391224128508 00763000406011224387126 00763000406011224852795 00613994445391224852796 00613994445391224878536 00613994445391224949834 00613994445391224949835 00613994445391224990657 00763000624798224990660 00613994445391224990846 00613994445391224990847 00763000624798224990889 00763000624798225198821 00613994445391225500036 00613994445391225500037 00613994445391225675930 00763000406011225675932 00613994445391225686835 00613994445391225749841 00763000406011226111239 00613994445391226242273 00763000624798226288883 00763000624798226335146 00613994445391226335147 00763000624798226335148 00613994445391226366036 00763000624798226420635 00763000406011226420636 00763000624798226517902 00613994445391226567491 00763000624798226616245 00763000624798226734637 00763000624798226734639 00763000624798226734641 00763000624798226734643 00763000624798226734645 00763000624798226734686 00763000624798226756274 00613994445391226899371 00763000406011226899373 00763000624798226899375 00613994445391
- Lot Number/GTIN
- Amount recalled
- 11,840 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for catheter disconnection from the patient line stopcock connectors.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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