Reported May 4, 2016 · Terminated
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
ev3, Inc.
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: ev3, Inc. · 3033 Campus Drive · Minneapolis, MN · 55441
Is this the product you have?
- ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter
- modelAB18W030200150, Sterile EO, Rx Only
- Lot codes and dates
- A213373 and A216702
- Amount recalled
- 27 (25 US, 2 OUS)
Where it was sold
Why it was recalled
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
This product could cause temporary or reversible health problems — stop using it.
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