Datascope Corp. 2025-12-17 Health serious FDA
Health · FDA · Recall #FDA-Z-0917-2026
Cardiosave Rescue. Intra-Aortic Balloon Pump system. Recall
Issued December 17, 2025 · Datascope Corp.
In December 2025, Datascope Corp. recalled the Cardiosave Rescue. Intra-Aortic Balloon Pump system., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
What you should do
- 1 Stop using Cardiosave Rescue. Intra-Aortic Balloon Pump system. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Datascope Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Datascope Corp.
- Category
- Health
- Recall date
- December 17, 2025
- Units affected
- Not reported
- Sold at
- Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Banglades
- Recall number
- FDA-Z-0917-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Datascope Corp. has 7 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.