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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Event Detail

Event ID 67437
Product Type Devices
Status Ongoing
Recalling Firm Boston Scientific Corporation
City Maple Grove
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-04
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151. 16310947 Class II 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. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. 35 for both products Z-0971-2014
Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121. 16397693 Class II 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. The most common adverse health consequence resulting from a balloon deflation failure is minor vessel trauma without the need for further intervention. 35 for both products. Z-0969-2014
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