Datascope recalls
Datascope appears in 134 official U.S. recall notices indexed by RecallRadar, most recently on 2026-03-25.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Battery Charging Station
FDA Device · Class III · 2026-03-25 · Datascope - CS300 IABP. Software Version CS300 IABP C.01
FDA Device · Class II · 2026-03-11 · Datascope - CS100 IABP. Software Version CS100 IABP Q.01
FDA Device · Class II · 2026-03-11 · Datascope - Cardiosave Rescue
FDA Device · Class III · 2025-12-24 · Datascope - Cardiosave Hybrid
FDA Device · Class III · 2025-12-24 · Datascope - Cardiosave Hybrid
FDA Device · Class II · 2025-12-17 · Datascope - Cardiosave Rescue
FDA Device · Class II · 2025-12-17 · Datascope - MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
FDA Device · Class II · 2024-11-13 · Datascope - CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class I · 2024-10-02 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2023-09-06 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class II · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-…
FDA Device · Class I · 2023-09-06 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class I · 2023-09-06 · Datascope - TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Pa…
FDA Device · Class II · 2023-08-02 · Datascope - LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
FDA Device · Class II · 2023-08-02 · Datascope - SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Desc…
FDA Device · Class II · 2023-08-02 · Datascope - MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Pa…
FDA Device · Class II · 2023-08-02 · Datascope - REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product De…
FDA Device · Class II · 2023-08-02 · Datascope - SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Des…
FDA Device · Class II · 2023-08-02 · Datascope - YAMATO PLUS IAB
FDA Device · Class II · 2023-08-02 · Datascope - SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Descript…
FDA Device · Class II · 2023-08-02 · Datascope - MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description…
FDA Device · Class II · 2023-08-02 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-07-26 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0…
FDA Device · Class I · 2023-07-26 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0…
FDA Device · Class I · 2023-07-26 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-07-26 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
FDA Device · Class III · 2023-06-21 · Datascope - MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
FDA Device · Class II · 2023-05-03 · Datascope - Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
FDA Device · Class II · 2023-03-29 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-…
FDA Device · Class II · 2023-03-29 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Device · Class II · 2023-03-29 · Datascope - Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
FDA Device · Class II · 2023-03-29 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75,…
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
FDA Device · Class II · 2023-03-15 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump
FDA Device · Class II · 2023-03-15 · Datascope - Cardiosave Rescue
FDA Device · Class II · 2023-03-15 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-…
FDA Device · Class II · 2023-03-15 · Datascope - Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-5…
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31,…
FDA Device · Class I · 2023-03-15 · Datascope - Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-…
FDA Device · Class I · 2023-01-25 · Datascope