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. .
FDA Recall Z-2074-2012 · Posted 2012-07-24
Recalling FirmBridgepoint Medical
Recall StatusTerminated
Product CodeDQY
Date Initiated2012-06-26
Date Terminated2012-09-06
Product Quantity95 (57 USA, 38 OUS)
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.
Firm 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 President of Quality Assurance, at 763-225-8511 or e-mail at [email protected].
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K102725CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND MBridge Medical, Inc. · 2011-05-10K101591STINGRAY ORIENTING BALLOON CATHETERBridgepoint Medical · 2010-08-06K080987BRIDGEPOINT MEDICAL STINGRAY DEVICE AND ACCESSORIESBridgepoint Medical · 2009-02-06
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.