Reported Mar 6, 2024 · Ongoing
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915,…
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, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 22216314000613994445384222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384 22243902900613994445384222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384 22281738700613994445384223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781; 226625848 00763000624781; 226632942 00763000624781; 226634688 00763000624781; 226634689 00763000624781; 226634690 00763000624781; 226665393 00763000624781; 226665394 00613994445384; 226665399 00763000624781; 226665400 00763000624781; 226665401 00763000624781; 226665403 00763000624781; 226665404 00763000624781; 226665405 00763000624781; 226665646 00763000624781; 226665647 00763000624781; 226665648 00763000624781; 226665650 00763000624781; 226732001 00763000624781; 226899377 00613994445384; 226951465 00613994445384; 226951467 00613994445384; 226951468 00613994445384; 226951469 00763000396008; 227136777 00763000624781; 227188108 00763000624781; 227194735 00763000624781 22719473600763000624781— - Amount recalled
- 14,139 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.
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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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