Reported Mar 6, 2024 · Ongoing
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only.…
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, REF 46914, 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
127 of 127 codes
221482529 00763000395971221520718 00763000395971221648854 00763000395971221687765 00763000395971221744158 00763000395971221744549 00763000395971221795479 00613994445377221827827 00613994445377221827828 00613994445377221873427 00763000395971221873428 00763000395971221915124 00763000395971221915125 00763000395971221916163 00613994445377221916164 00763000395971221955230 00763000395971221955231 00763000395971222015665 00613994445377222061755 00613994445377222204094 00613994445377222345104 00613994445377222345105 00613994445377222346067 00613994445377222393929 00763000395971222393930 00763000395971222530273 00613994445377222543362 00763000395971222543363 00763000395971222580924 00613994445377222970856 00613994445377222970857 00613994445377222970858 00613994445377222999295 00613994445377222999296 00613994445377223070846 00763000395971223130156 00763000395971223165960 00763000395971223165961 00763000395971223165962 00763000395971223251949 00763000395971223580360 00763000624774223620063 00763000624774223621055 00763000624774223659559 00763000624774223659560 00763000624774223698571 00763000624774223734521 00763000624774223734522 00763000624774223778509 00763000624774223999041 00613994445377224032597 00763000624774224173197 00763000395971224342656 00763000395971224387139 00763000395971224852792 00763000624774224852793 00763000624774224852794 00763000624774224877792 00763000624774224878534 00763000624774224878535 00763000624774
- Lot Number/GTIN
- Amount recalled
- 32,404 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.
Free recall alerts
Get alerted about new Medtronic Neurosurgery recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.