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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
Recall Number Z-0971-2014
Classification Class II
Code Info 16310947
Product Distributed Qty 35 for both products
Reason For Recall 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.

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.
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