There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
Reason for recall: There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy. Distribution: Distribution list not yet provided. Quantity: 391 total IABPs Lot/code info: Model Number: 0998-00-0800-31, UDI-DI: 10607567109053; Model Number: 0998-00-0800-32, UDI-DI: 10607567111117; Model Number: 0998-00-0800-33, UDI-DI: 10607567109008; Model Number: 0998-00-0800-35, UDI-DI: 10607567109107; Model Number: 0998-00-0800-45, UDI-DI: 10607567108421; Model Number: 0998-00-0800-52, UDI-DI: 10607567108438; Model Number: 0998-00-0800-53, UDI-DI: 10607567108391; Model Number: 0998-00-0800-55, UDI-DI: 10607567108414; Model Number: 0998-00-0800-65, UDI-DI: 10607567113432; Serial Numbers: CB355244F2, CB355245F2, CB356759G2, CB356760G2, CB351303D2 CB355431F2 CB355432F2 CB355433F2 CB355434F2 CB355435F2 CB356761G2 CB356762G2 CB356763G2 CB356764G2 CB356765G2 CB351313D2 CB352952E2 CB352953E2 CB355240F2 CB355241F2 CB355242F2 CB355243F2 CB356766G2 CB356767G2 CB356768G2 CB356769G2 CB356770G2 CH351787D2 CH352224D2 CH352225D2 CH352228D2 CH352280E2 CH352283E2 CH352284E2 CH352287E2 CH352289E2 CH352290E2 CH352297E2 CH352298E2 CH353439E2 CH353443E2 CH353445E2 CH353448E2 CH353451E2 CH353454E2 CH353795F2 CH353796F2 CH353797F2 CH353798F2 CH353799F2 CH353801F2 CH353802F2 CH353803F2 CH353804F2 CH353805F2 CH353806F2 CH353807F2 CH353808F2 CH353809F2 CH353810F2 CH353811F2 CH353812F2 CH353813F2 CH353814F2 CH354143F2 CH354144F2 CH354145F2 CH354146F2 CH354147F2 CH354148F2 CH354149F2 CH354150F2 CH354151F2 CH354152F2 CH354153F2 CH354154F2 CH354155F2 CH354156F2 CH354157F2 CH354158F2 CH354159F2 CH354160F2 CH354161F2 CH354162F2 CB351043D2 CB351792D2 CB352956E2 CB353456E2 CB354411F2 CB3544
10607567109053, 10607567111117, 10607567109008, 10607567109107, 10607567108421, 10607567108438, 10607567108391, 10607567108414, 10607567113432
Official record: FDA (Device enforcement) ↗
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