BEUDAMED
    FDA Recall Open, Classified

    Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

    Recall: Z-0605-2024 · Initiated November 13, 2023

    Recall

    Recall Number
    Z-0605-2024
    Event Number
    93563
    Firm
    Maquet Medical Systems USA
    FEI Number
    3008355164
    Product Code
    DTQ
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    November 13, 2023
    Posted
    December 21, 2023
    Address
    45 Barbour Pond Dr, Wayne, NJ, 07470-2094

    Description

    Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802

    Reason

    Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be exposed to inappropriate blood flow, blood temperature, or hematocrit/hemoglobin levels as a result of the CARDIOHELP-i not receiving information from the venous probe.

    Action

    On November 13, 2023, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letter. Customers were informed that if they have an older version of the venous probe connection cable, Getinge will replace the cable at no charge to their facility. If the Venous probe connection cable shows any visible indication of breakage or if the CARDIOHELP-i displays an error instructing you to "replace venous probe or cable", please discontinue use and contact Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). Getinge will provide instructions on the return of the cable and arrange for a replacement to be sent at no charge to your facility. Affected CARDIOHELP-i devices do not need to be returned while awaiting replacement of the venous probe cable. As noted in the Service Manual, please check whether there is any visible damage to the venous probe unit and cables before use. Getinge has been distributing a redesigned venous probe cable since April 2019.

    Distribution

    Domestic distribution Nationwide. Foreign distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Canada, Cayman Islands, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Islamic Republic Of Iraq, Italy, Japan, Kazakhstan, Korea, Republic Of Kuwait, Latvia, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    1213 US, 2589 OUS