Datascope Corp. recalls Cardiosave Hybrid. Intra-Aortic Balloon Pump system.

Recall date

November 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0916-2026

FDA classification

Class II

Brand / firm

Datascope Corp.

Sold / distributed

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, Cz…

Why it was recalled

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiosave Hybrid. Intra-Aortic Balloon Pump system.