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U.S. Department of Health and Human Services

Class 2 Device Recall 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation Catheter

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  Class 2 Device Recall 2.5mm Coyote OVERTHEWIRE PTA Balloon Dilation Catheter see related information
Date Initiated by Firm February 04, 2014
Date Posted February 11, 2014
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-0969-2014
Recall Event ID 67437
510(K)Number K111295  
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
Product Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121.
Code Information 16397693
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Brent Hathcock
763-494-1133
Manufacturer 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. T
FDA Determined
Cause 2		 Device Design
Action Consignees were sent a Boston Scientific " Urgent Medical Device Recall Removal" letter on 2/4/2014. The letter was addressed to Materials Manager and Field Action Contact. The letter described the product involved in the recall and the problem. Advised consignees to segregate the affected lots and return to Boston Scientific in accordance to the enclosed recall instructions. The instructions also requested consignees to complete and return the Account Reply Verification Tracking Form (RVTF).
Quantity in Commerce 35 for both products.
Distribution US: AL, CA, FL, IL, IN, MI, MO, NY, OH, PA, TX. OUS: ITALY, GERMANY, FRANCE, GREAT BRITAIN, NETHERLANDS, WHITE RUSSIA, INDIA, JAPAN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = Boston Scientific Corporation
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