Medical device recalls Moderate risk

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump recalled over fire hazard

Recall date
January 30, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Maquet Datascope Corp - Cardiac Assist Division recalls Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Recall number
Z-1140-2015
FDA classification
Class II
Brand / firm
Maquet Datascope Corp - Cardiac Assist Division
Sold / distributed
US Nationwide distribution

Why it was recalled

Power supply malfunction complaints related to suboptimal thermal management.

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

What was recalled

Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)

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