BEUDAMED
    FDA Recall Terminated

    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

    Recall: Z-2309-2021 · Initiated July 14, 2021

    Recall

    Recall Number
    Z-2309-2021
    Event Number
    88334
    Firm
    Ostial Corporation
    FEI Number
    3008700817
    Product Code
    LIT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 14, 2021
    Terminated
    January 30, 2024
    Address
    197 E Hamilton Ave, Ste 101, Campbell, CA, 95008-0261

    Description

    FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA

    Reason

    Angioplasty system has a manufacturing issue that has the potential to result in difficulty deflating the outer balloon, which may result in increased risk of access site complications.

    Action

    On 07/14/2021, recall notices were mailed to customers. Customers were asked to take the following actions: 1) Immediately examine your inventory and quarantine product subject to recall. 2) Return all unused inventory to the recalling firm. Please contact Customer Service at 844 352-7411. 3) Please complete the enclosed Customer Acknowledgement Form and submit to [email protected]. 4) Please forward a copy of this notification to those within your organization that need to be aware. Customers with additional questions or concerns are encouraged to contact Customer Service at 844-352-7411 Monday-Friday/8am-4pm PST or contact your local Field Representative.

    Distribution

    US Nationwide distribution in the states of AZ, MI, OH, IN, KY, MT, FL, PA, GA, MN, KS, NY, IL, SD, LA, SC, CT.

    Quantity

    40