BEUDAMED
    FDA Enforcement Class II Ongoing

    Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

    Recall: Z-0486-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0486-2025
    Event ID
    95614
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Maquet Cardiovascular, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    October 16, 2024
    Classification Date
    November 18, 2024
    Address
    45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States

    Description

    Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

    Reason

    Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.

    Code Info

    Model Number C-OM-10000Z. UDI-DI Number: 00607567100008. Batch Numbers: 3000277221, 3000286549, 3000315868, 3000317517, 3000322538, 3000339447, 3000363028, 3000270713, 3000275435, 3000275771, 3000280868, 3000284390, 3000303149, 3000321642, 3000342528, 3000336070, 3000322179, 3000337396, 3000273182, 3000282181, 3000337880, 3000353535, 3000364172, 3000357109, 3000276109, 3000338107, 3000354445, 3000355050, 3000352899, 3000324785, 3000360894, 3000370720, 3000323627, 3000346330, 3000356740, 3000278665, 3000344012, 3000366729, 3000361801, 3000400928, 3000363775, 3000311956, 3000343553, 3000367559, 3000377818, 3000341430, 3000367345, 3000336377, 3000316208, 3000381449, 3000380956, 3000403756, 3000321414, 3000361499, 3000407809, 3000398030, 3000387678, 3000320077, 3000277072, 3000283754, 3000296552, 3000320660, 3000339096, 3000347694, 3000348390, 3000352250, 3000279303, 3000277309, 3000282794, 3000283482, 3000350599, 3000351774, 3000351996, 3000365741, 3000369223, 3000369738, 3000393258, 3000323129, 3000273547, 3000366133, 3000391146, 3000273843, 3000280827, 3000295912, 3000346410, 3000401855, 3000384033, 3000382967, 3000378703, 3000363755, 3000316146, 3000295949, 3000398861, 3000394893, 3000380542, 3000361797, 3000350598, 3000320073, 3000299042, 3000295186, 3000288696, 3000284723, 3000274876, 3000363227, 3000285664.

    Distribution

    Nationwide distribution. International distribution to Albania, Algeria, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brunei Canada, Croatia, Czech Republic, Denmark, Finland, France and Belarus, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Lebanon, Luxembourg, Malaysia, Netherlands, Oman, Pakistan, Poland, Portugal, Slovenia, South Africa, Spain, Switzerland, the Republic of Korea (South Korea), Turkey, United Arab Emirates, United Kingdom.

    Quantity

    33,823 units