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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012
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Event Detail

Event ID 62450
Product Type Devices
Status Ongoing
Recalling Firm Bridgepoint Medical
City Minneapolis
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-26
Initial Firm Notification of
Consignee or Public		 Letter
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. . Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080 Class II 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. 95 (57 USA, 38 OUS) Z-2074-2012
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