BEUDAMED
    FDA Recall Open, Classified

    Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

    Recall: Z-0916-2026 · Initiated November 4, 2025

    Recall

    Recall Number
    Z-0916-2026
    Event Number
    97946
    Firm
    Datascope Corp.
    FEI Number
    3001418283
    Product Code
    DSP
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    November 4, 2025
    Posted
    December 11, 2025
    Address
    1300 Macarthur Blvd, Mahwah, NJ, 07430-2052

    Description

    Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

    Reason

    The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

    Action

    An URGENT MEDICAL DEVICE CORRECTION NOTICE, dated October 2025, was sent via FEDEX to consignees. The notification notifies consignees of four addendum updates: 1) NVRAM Preventive Maintenance (New FSCA - reflected in this recall entry), 2) Vibration and Shock Table Specifications (New FSCA), 3) Helium O-Ring Preventive Maintenance (FSCA 2249723-01/24/2023-004-C), and 4) Battery Runtime Specifications (FSCA 2249723-09/10/2021-001-R). The notification instructs consignees regarding the NVRAM Preventive Maintenance to review the provided IFU addendum, update local preventive maintenance procedures as such, and ensure all NVRAM batteries are within their life expectancy. If a NVRAM is greater than 8 years old, until it can be replaced, it is advised a back-up Cardiosave IABP be available to provide therapy. Consignees with any questions can contact Datascope/Getinge Customer Support at 1-88-943-8872 (options 4, 2, 1) Monday through Friday, from 8:00 AM EST and 6:00 PM EST.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.

    Quantity

    11,470 units