FDA Device recall Z-0917-2026
Cardiosave Rescue
- FDA Device
- Class II
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class II recall of Cardiosave Rescue by Datascope, citing the IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0917-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-04 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Reason
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Identifiers
| code_info | Model No. (UDI): 0998-00-0800-83 (10607567108407); ALL SERIAL NO. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2026%22
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