Recall Z-0076-2022 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
| Date | Oct 7, 2021 (initiated Sep 8, 2021) |
| Status | Open, Classified |
| Reason | The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. |
| Root cause | Device Design |
| Action | On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue experience the following issue: Helium Indicator Inaccuracy in the Presence of Continuous EMC Disturbances. Customers were provided with actions to take to limit the possibility of loss of therapy due to an over-reporting of remaining helium on the Helium Indicator. Cardiosave Hybrid users should view the mechanical gauge on the Cardiosave Top Panel to assess remaining helium capaci |
| Quantity | 5054 total (US); 5033 total (OUS) |
| Distribution | Worldwide distribution - 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 |