BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-2074-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2074-2012
    Event ID
    62450
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bridgepoint Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    June 26, 2012
    Classification Date
    July 24, 2012
    Termination Date
    September 6, 2012
    Address
    13355 10th Ave N, Suite #110, Minneapolis, MN, 55441-5553, United States

    Description

    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. .

    Reason

    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 Info

    Lots affected in US: BP20121440078, BP20121560089 Lots affected OUS: BP20121510086, BP20121500080

    Distribution

    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.

    Quantity

    95 (57 USA, 38 OUS)