Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U,…

Recall date

July 27, 2020

Source

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

Recall number

Z-2837-2020

FDA classification

Class II

Brand / firm

Datascope Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia,…

Why it was recalled

Potential Endotoxin Contamination

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

What was recalled

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.