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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 25 of 25 Results
510(K) Number: K112372
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Product Description
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Recall
Class
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FDA Recall
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Cardiosave Hybrid 3 12/16/2025 FEI # 3001418283
Datascope Corp.
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for ... 2 02/07/2015 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intr... 2 01/09/2013 FEI # 2242352
Maquet Cardiovascular, LLC
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion ... 2 03/02/2017 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
Battery Charging Station; Model: 0998-00-0802; 3 03/19/2026 FEI # 3001418283
Datascope Corp.
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