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ev3, Inc. recalls ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Recalled May 4, 2016 · FDA recall Z-1552-2016 · ev3
Hazard
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. · FDA Class II
Units
27 (25 US, 2 OUS)
Sold at
US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Description
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.
Product
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Manufacturer(s)
ev3, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →