BridgePoint Medical Recalls Stingray Catheters Due to Sterility Concerns
BridgePoint Medical is voluntarily recalling Stingray Catheters because a faulty pouch seal may have compromised sterility assurance. No adverse clinical events have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
BridgePoint Medical Inc. is voluntarily recalling Stingray Catheters, Model M1000, specifically lots BP20121440078 and BP20121560089. The recall was initiated after the company determined that a faulty pouch seal created the potential for compromised sterility assurance of the product.
The affected devices are prescription-only medical devices intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions prior to PTCA or stent intervention. The recall covers 95 units, with 57 distributed in the USA and 38 distributed outside the USA. Distribution in the United States was nationwide, including specific states such as Alabama, Arizona, California, Colorado, Georgia, Illinois, Kentucky, Maryland, Minnesota, Missouri, North Carolina, New York, Oregon, Pennsylvania, Washington, and Wisconsin. The product was also distributed in Australia and Sweden.
BridgePoint Medical stated that in no case was there any reported adverse clinical event related to the problem. Consumers and healthcare providers should check their inventory for the specific lot numbers listed and contact the manufacturer or their supplier for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- 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…
- Manufacturer
- Bridgepoint Medical
- Category
- Medical Device — Cardiovascular
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots affected in US: BP20121440078
- BP20121560089 Lots affected OUS: BP20121510086
- BP20121500080
Distribution
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