Maquet Datascope Corp - Cardiac Assist Division recalls Cardiosave Hybrid and rescue IABP

Recall date

December 16, 2015

Source

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

Recall number

Z-1248-2016

FDA classification

Class II

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

Worldwide Distribution- Nationwide Distribution including Puerto Rico.

Why it was recalled

Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.

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 and rescue IABP