Recall Z-2434-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
| Date | Aug 30, 2023 (initiated Jul 31, 2023) |
| Status | Open, Classified |
| Reason | Users reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode. |
| Root cause | Device Design |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. System Over-Temperature User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. When a System Over Temperature alarm is triggered, the device must be powered down andallowed to cool to a safe operating internal temperature before therapy can be re-initiated using the same IABP.Should |
| Quantity | 47 units (42 US, 5 OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp., May 31, 2018 |