Recall Z-0091-2022 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998
| Date | Oct 20, 2021 (initiated Sep 21, 2021) |
| Status | Open, Classified |
| Reason | A Cardiosave Lithium-Ion Battery Pack used during protocol testing failed to meet the minimum runtime requirement per Getinge internal Product Specification. These nonconforming batteries were inadvertently released to customers. |
| Root cause | Nonconforming Material/Component |
| Action | On September 21, 2021, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were alerted that affected battery packs may experience unexpected short battery runtime. Actions to be Taken by Customer: - Examine your inventory to determine if you have any of the affected product - Replace any affected battery with an unaffected battery, and remove affected product from areas of use - Dispose of affected batteries properly in accordance with local statutes and the labeling on the battery pack - Customers with affected product are eligible for credit or repl |
| Quantity | 131 batteries, 11,517 pumps |
| Distribution | Worldwide distribution. US nationwide, Australia, Brazil, Bahrain, Belgium, Canada, China, Czech Republic, Egypt, France, Germany, India, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, Pakistan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, T |
| 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 |
| K151254 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump Datascope Corp., Jul 2, 2015 |
| K163542 | CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp., Jan 31, 2017 |
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp., May 31, 2018 |