Bridgepoint Medical
Country not established
- Devices
- 14
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Bridgepoint Medical makes
Bridgepoint Medical manufactures coronary and peripheral guidewires, orienting balloon catheters, and specialized catheters designed for interventional cardiology procedures. Products include the Stingray Orienting Balloon Catheter, BigBoss and CrossBoss percutaneous coronary catheters, and Mantaray catheters and guidewires, which support vessel access and dilation in coronary and peripheral arteries.
The company’s devices are classified as Class II under the FDA and are listed via the 510(k) pathway. These products are regulated in the United States, where Bridgepoint Medical is based.
Catalogue
Search and filter all 14 devicesFDA recalls
FDA recall records list 1 recall initiated by Bridgepoint Medical, initiated on 2012-06-26. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 26 Jun 2012 Z-2074-2012 Class II Terminated 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.
Full distribution text
- 26 Jun 2012 Z-2074-2012 Class II Terminated 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.
Frequently asked questions
How many devices does Bridgepoint Medical have in the registry?
The registry currently lists 14 devices for Bridgepoint Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bridgepoint Medical's devices?
Among its 14 most recently registered devices, Bridgepoint Medical has devices listed in FDA 510(k) (14 devices).
What risk classes do Bridgepoint Medical's devices fall under?
Among its 14 most recently registered devices, the classes recorded for Bridgepoint Medical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bridgepoint Medical?
FDA recall records list 1 recall initiated by Bridgepoint Medical, the most recent initiated on 2012-06-26. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bridgepoint Medical in the registry?
The most recently registered devices listed for Bridgepoint Medical include STINGRAY ORIENTING BALLOON CATHETER, BIGBOSS CATHETER, BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 and BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES.