Recall Z-0916-2026 · DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
| Date | Dec 11, 2025 (initiated Nov 4, 2025) |
| Status | Open, Classified |
| Reason | The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023. |
| Root cause | Component design/selection |
| Action | An URGENT MEDICAL DEVICE CORRECTION NOTICE, dated October 2025, was sent via FEDEX to consignees. The notification notifies consignees of four addendum updates: 1) NVRAM Preventive Maintenance (New FSCA - reflected in this recall entry), 2) Vibration and Shock Table Specifications (New FSCA), 3) Helium O-Ring Preventive Maintenance (FSCA 2249723-01/24/2023-004-C), and 4) Battery Runtime Specifications (FSCA 2249723-09/10/2021-001-R). The notification instructs consignees regarding the NVRAM Preventive Maintenance to review the provided IFU addendum, update local preventive maintenance procedur |
| Quantity | 11,470 units |
| Distribution | Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Cze |
| FDA record | Open on fda.gov |