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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 25 Results
510(K) Number: K112372
 
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Battery Charging Station; Model: 0998-00-0802; 3 03/19/2026 FEI # 3001418283
Datascope Corp.
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
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intr... 2 01/09/2013 FEI # 2242352
Maquet Cardiovascular, LLC
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 Hybrid 3 12/16/2025 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provid... 3 04/28/2021 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 10/07/2021 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 09/30/2021 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, ... 2 03/06/2023 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, ... 2 03/22/2023 FEI # 3001418283
Datascope Corp.
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