Reported Jan 6, 2021 · Ongoing
Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Ares Antibiotic-Impregnated Catheter
- REF93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated
- Lot codes and dates
- Lot numbers
0010258435001028139000103123600010353505001038490000102738890010281391001031236100103535070010384901001027389000102813920010312362001036936600103849030010273891001028983500103169590010369367001039322000102738930010289836001031696000103767840010393221001027841800102976780010316961001037678500102784270010305929001031696300103767860010281384001030593700103366200010384897
- Lot numbers
- Amount recalled
- 1,926 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.
This product could cause temporary or reversible health problems — stop using it.
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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