Recall Z-2436-2023 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
| Date | Aug 30, 2023 (initiated Jul 31, 2023) |
| Status | Open, Classified |
| Reason | Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Gas Loss & Gas Gain Alarms 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) affected by this correction in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The following actions should be taken should you experience an alarm for Gas Loss in IAB & Gas Gain in IAB : Gas Gain in IAB Circuit " Verify all of the tubing connection |
| Quantity | 9175 units |
| 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 |