Datascope Corp. recalls MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Recall date

September 17, 2024

Source

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

Recall number

Z-0311-2025

FDA classification

Class II

Brand / firm

Datascope Corp.

Sold / distributed

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

Why it was recalled

There is discrepant labeling on the inner and outer packaging of the device.

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

What was recalled

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01