Recall Z-0931-2026 · DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid
| Date | Dec 16, 2025 (initiated Oct 23, 2025) |
| Status | Open, Classified |
| Reason | The IFU addendum updates the Vibration and Shock Table to reference the correct standards. |
| Root cause | Process change control |
| Action | On November 4, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: 1. Review the IFU Addendum. An IFU Addendum was created to reference the appropriate Transportation Standards that were tested in product specifications. Please forward this information to all current and potential Cardiosave IABP users within your facility. Complete and sign the attached Response Form to acknowledge that you have received and understand this notification. Return the completed form to recallresponses.qrc@getinge.com. If you are a distributor who has shipped any affected pr |
| Quantity | 11470 units (5095 US, 6375 OUS) |
| Distribution | Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿ |
| 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 |