FDAFDA · Food and drugs·Recall number Z-0969-2014
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
Published February 19, 2014 · Recall initiated: February 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Boston Scientific is initiating this Recall Removal of one lot of the Coyote" OVER-THE-WIRE PTA Balloon Dilatation Catheter and one lot of the Coyote" MONORAIL" PTA Balloon Dilatation Catheter. Boston Scientific has become aware that the balloons of the devices from these lots may not deflate as expected during a procedure. To date, Boston Scientific has received three complaints for this issue. T
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.
- Lot
- 16397693
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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