Recall Z-1276-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
| Date | Mar 22, 2023 (initiated Feb 28, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 391 total IABPs |
| Distribution | Distribution list not yet provided. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |