Recall Z-2074-2012 ยท DQY Catheter, Percutaneous
Bridgepoint Medical
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent interven
| Date | Jul 24, 2012 (initiated Jun 26, 2012) |
| Status | Terminated |
| Reason | BridgePoint Medical Inc. is voluntarily recalling Stingray Catheter, Model M1000 lots BP20121440078 and BP20121560089. BridgePoint Medical, Inc. recently determined the potential of compromised sterility assurance of the product due to a faulty pouch seal. In no case was there any reported adverse clinical event related to the problem. |
| Root cause | Process control |
| Action | The firm, BridgePoint Medical, sent an "Urgent Field Safety Notice" letter dated June 26, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory, quarantine the affected lots and complete and return the enclosed "Verification Form" via fax to 763-225-8718 ,attn: BridgePoint Medical, Inc., Upon receipt of form, BridgePoint will supply the customers with the appropriate materials to return the products. If you have any questions regarding this notice, please call BridgePoint Medical, Vice Pr |
| Quantity | 95 (57 USA, 38 OUS) |
| Distribution | Worldwide distribution: USA (nationwide) including: AL, AZ, CA, CO, GA, IL, KY, MD, MN, MO, NC, NY, OR, PA, WA, and WI; and countries of: Australia and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080987 | BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIES Bridgepoint Medical, Feb 6, 2009 |
| K101591 | STINGRAY ORIENTING BALLOON CATHETER Bridgepoint Medical, Aug 6, 2010 |
| K102725 | CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M Bridge Medical, Inc., May 10, 2011 |