Recall Z-1146-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
| Date | Mar 9, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| Reason | An unexpected shutdown of the IABP may occur due to a failure of the connection between the Coiled Cord cable and the Cable Assembly backplane to the Coiled Cord cable which provides the communication between the display head and base unit. |
| Root cause | Under Investigation by firm |
| Action | The firm sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 2/7/23 to customers. The customers were instructed to do the following actions: Examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. Prior to use of the Cardiosave IABP, inspect the coiled cable cord to ensure that there is no visible damage. Should you experience an unexpected shutdown of the Cardiosave IABP during therapy, or a present frozen or black screen, utilize another IABP to continue therapy. Until an alternative IABP is located you may attempt to restart the IABP. If |
| Quantity | 4062 Total |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (Foreign) ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, BRUNEI , BULGARIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GHANA, HONG KONG, ICELAND, INDIA, INDONESIA, IRAN, I |
| 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 |