BEUDAMED
    FDA Recall Open, Classified

    Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

    Recall: Z-0100-2019 · Initiated September 20, 2018

    Recall

    Recall Number
    Z-0100-2019
    Event Number
    81055
    Firm
    Maquet Datascope Corp Cardiac Assist Division
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    September 20, 2018
    Posted
    October 27, 2018
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

    Reason

    There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

    Action

    On September 20, 2018, Maquet/Getinge issued a press release. On September 24, 2018 and on September 28, 2018, Maquet/Getinge issued URGENT MEDICAL DEVICE CORRECTION notices along with an Instructions for Use Addendum to customers. On October 23, 2018 a modified version of the Urgent Medical Device Correction Letter and response form was sent to 23 new U.S. consignees who received Cardiosave IABP devices after the ship-hold was released. The post ship-hold devices contain the IFU addendum. This modified version of the letter notifies customers of the altitude issue and the required software update. Maquet/Getinge is currently developing a software correction to address this issue. Customers are encouraged to use the following items as specified according to altitude levels: Sensation 34cc / 40cc (Balloon Name and Size) Sensation Plus 40cc / 50cc (Balloon Name and Size) Operating Altitude: -1250 feet to 3,200 feet (795 mmHg to 676 mmHg) (1060 hPa to 901 hPa) Mega 50cc (Balloon Name & Size) Operating Altitude: -1250 feet to 5000 feet (795 mmHg to 632 mmHg) (1060 hPa to 843 hPa) Mega 30cc / 40cc (Balloon Name & Size) Linear 25cc / 34cc / 40cc (Balloon Name & Size) Operating Altitude: -1250 feet to 12,000 feet (795 mmHg to 483 mmHg) (1060 hPa to 644 hPa) For technical questions, please contact Technical Support Department (at 1-888-627-8383 and press 3), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST

    Distribution

    US Nationwide; Internationally to 77 countries