Recall Z-0971-2014 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Boston Scientific Corporation
Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151.
| Date | Feb 11, 2014 (initiated Feb 4, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111295 | .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS Boston Scientific Corporation, May 31, 2011 |