—#125452

Product

Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.

FDA product code: LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K111295
Affected lot / code info: 16310947

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

Root cause (FDA determination)

Device Design

Action the firm took

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).

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

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.

Timeline

Recall initiated: 2014-02-04
Posted by FDA: 2014-02-11
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125452. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.