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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 27 of 27 Results
510(K) Number: K112372
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Product Description
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FDA Recall
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Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, ... 2 03/06/2023 Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, ... 2 03/06/2023 Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model UDI 0998-00-0800-75 1060756711... 1 12/30/2021 Datascope Corp.
Cardiosave Hybrid IntraAortic Balloon Pump. Model UDI 0998-00-0800-31 1060756710... 1 12/30/2021 Datascope Corp.
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aor... 1 10/20/2021 Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 10/07/2021 Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 09/30/2021 Datascope Corp.
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