Reported Feb 19, 2014 · Terminated
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Boston Scientific Corporation
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: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
- Lot codes and dates
- 16310947
- Amount recalled
- 35 for both products
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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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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