Recall Z-1277-2023

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.

FDA-determined cause: Under Investigation by firm

Action taken

An URGENT MEDICAL DEVICE CORRECTION dated 2/28/23 was sent to customers. User Actions to be taken: A review of our records indicate that you may have a Cardiosave IABP at your facility with an affected Safety Disk or affected spare Safety Disks or PIM assembly installed recently into Cardiosave IABP. 1. Please examine your inventory immediately to determine if you have any Cardiosave IABPs with the affected Safety Disks and/or PIM, or any affected Safety Disk and/or PIM assembly spare parts, per attachment 1. 2. You may continue to use any affected IABPs until replacement parts are installed. Please keep in mind the potential health risks cited above, particularly with prolonged heart rates above 100 beats per minute for three consecutive hours. When transporting patients outside the hospital environment, consider using an unaffected console if available. 3. Should you have any unused affected spare parts of the Safety Disk or PIM Assembly in your inventory, please remove them from areas of use and contact your local Datascope/Getinge Customer Service department at 888-9GETUSA (888 943-8872) to request a return authorization (RMA) and shipping instruction to return the affected product for credit. 4. If you installed an affected spare part into one of your IABPs the Safety Disk will need to be replaced. 5. If you purchased spare parts and they are no longer in your inventory and you are unsure of their location, please contact Getinge Service. Getinge Service will schedule an on-site visit to inspect your IABP/(s) at no cost to your facility. 6. Should you have any affected Cardiosave IABPs you will be contacted by a Getinge Service Representative to schedule an on-site visit to replace the Safety Disk, free of charge. You can also arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone