device · product 1 of 1
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 intervention. When used as part of the BridgePoint Medical System, the Stingray Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention. .
- Recall number
- Z-2074-2012
- Initiated
- June 26, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Bridgepoint Medical
- Quantity
- 95 (57 USA, 38 OUS)
App-derived interpretation
Sterility assurance
compromised sterility
Official device-enrichment evidence · Sourced
Process control
Inspect official wording and provenance
Reason for recall
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.
Code information
Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080
Distribution pattern
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.