Recall Z-2486-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
| Date | Aug 31, 2023 (initiated Jul 31, 2023) |
| Status | Open, Classified |
| Reason | Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Fiber Optic Damage 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. Fiber optics assists in the rapid acquisition and accuracy of the arterial pressure waveform although it is not required to provide therapy with a fiber optic catheter. As detailed within the IFU and educationa |
| Quantity | 9379 units |
| Distribution | US Nationwide. Global 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 |