Cardiosave Rescue
FDA device recall Z-0932-2026 · posted 2025-12-16 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- Reason for recall
- The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
- Action taken
- 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 products to customers, please forward this document to their attention for appropriate action. Actions to be taken by Datascope: Datascope created an IFU Addendum with a clarification to the Vibration and Shock Table IFU information. If you require a physical copy, please contact your local Datascope/Getinge representative, and one will be provided to you at no cost. We apologize for any inconvenience this correction may cause. If you have any questions, please call Datascope/Getinge Customer Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 47 units (44 US, 3 OUS)
- Distribution
- Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovi
- Date initiated
- 2025-10-23
- Date posted
- 2025-12-16
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE Intra-Aortic Balloon Pump (K181122) | Datascope Corp. | 2018-05-31 |
| CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542) | Datascope Corp. | 2017-01-31 |
| CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254) | Datascope Corp. | 2015-07-02 |
| CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (K112372) | Cardiac Assist, Maquet Cardiovascular, LLC | 2011-09-15 |