Datascope Corporation recalls LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Recall date

August 5, 2022

Source

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

Recall number

Z-0131-2023

FDA classification

Class II

Brand / firm

Datascope Corporation

Sold / distributed

No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.

Why it was recalled

The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.

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

What was recalled

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.