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Class 2 Device Recall Coyote MONORAIL PTA Balloon Dilatation Catheter |
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Date Initiated by Firm |
February 04, 2014 |
Date Posted |
February 11, 2014 |
Recall Status1 |
Terminated 3 on August 04, 2014 |
Recall Number |
Z-0971-2014 |
Recall Event ID |
67437 |
510(K)Number |
K111295
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Product Classification |
Catheter, angioplasty, peripheral, transluminal - Product Code LIT
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Product |
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
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Code Information |
16310947 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Scimed Pl Maple Grove MN 55311-1565
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For Additional Information Contact |
Brent Hathcock 763-494-1133
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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
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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
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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.
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510(K) Database |
510(K)s with Product Code = LIT and Original Applicant = Boston Scientific Corporation
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