Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

Recall date

September 20, 2018

Source

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

Recall number

Z-0099-2019

FDA classification

Class I

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

US Nationwide; Internationally to 77 countries

Why it was recalled

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Cardiosave Hybrid IABP, Part Number 0998-00-0800-53