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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