Datascope Corp.: Medical Device Recalls in 2023

According to to data from the FDA, there were 39 medical device recalls made by Datascope Corp. in 2023. See the details of the recalls below.

You can see similar recalls for other firms.

• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
• Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• 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, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, and 0998-00-0800-55
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55
• 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 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* * -- not distributed in US
• 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 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
• SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES D684-00-0576-01 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-03 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (WITH PRESSURE D684-00-0576-05 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0576-09 SENSATION PLUS 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0576-01U PACKAGED INSERTION KIT - SENSATION PLUS 8 Fr. 50 cc IAB D884-00-0019-23
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• 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-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (WITH PRESSURE D684-00-0568-05 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (TURKEY) D684-00-0568-09 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES, US ONLY D684-00-0568-01U PACKAGED INSERTION KIT - SENSATION PLUS 7.5 Fr. 40 cc IAB D884-00-0019-22
• YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-01 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0559-02 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-01 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0560-02 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-01 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT D684-00-0561-02 PACKAGED INSERTION KIT - YAMATO PLUS-R 7.5 Fr. 30/35/40 cc IABs D886-00-0019-25
• MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0295-01 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0295-02 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0295-03 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0295-05 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0295-06 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0295-07 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES W/O STATLOCK (APA) - INDIA D684-00-0295-08 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0295-09 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0295-10 MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0295-01U MEGA 7.5Fr. 40cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0295-02U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES D684-00-0294-01 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) D684-00-0294-02 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0294-03 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (CHINA) D684-00-0294-05 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES AND APA (CHINA) D684-00-0294-06 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK - INDIA D684-00-0294-07 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES W/O STATLOCK (APA) INDIA D684-00-0294-08 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (TURKEY) D684-00-0294-09 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES (APA) (TURKEY) D684-00-0294-10 MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES, US ONLY D684-00-0294-01U MEGA 7.5Fr. 30cc IAB WITH ACCESSORIES APA, US ONLY D684-00-0294-02U PACKAGED INSERTION KIT - MEGA 7.5 Fr. 30/40 cc IABs D884-00-0019-21
• REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SET FOR LINEAR 7.5Fr. & MEGA 7.5Fr. D684-00-0403-05 REINFORCED INTRODUCER SET FOR SENSATION 7Fr. D684-00-0403-06 REINFORCED INTRODUCER SET FOR SENSATION PLUS & MEGA 8Fr. D684-00-0403-10
• TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 40cc IAB WITH ACCESSORIES D684-00-0546-01 TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIES D684-00-0607 TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES D684-00-0608 PACKAGED INSERTION KIT - TRANS-RAY 7 Fr. 34/40 cc IABs D884-00-0019-18 PACKAGED INSERTION KIT - TRANS-RAY PLUS 7.5 Fr. 35/40 IABs D884-00-0019-26
• Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
• Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk, Model Number 0202-00-0140
• MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
• SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0469-01C SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0469-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0470-01C SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0470-07 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0470-09 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES D684-00-0470-01 SENSATION 7 Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0470-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0469-01U SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES D684-00-0469-01 SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES, TURKEY D684-00-0469-09 PACKAGED INSERTION KIT - SENSATION 7 Fr. 34/40 cc IABs D884-00-0019-16
• 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, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
• 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 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
• 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-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
• 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-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
• LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES D684-00-0479-01 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) D684-00-0479-02 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (CHINA) D684-00-0479-01C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0479-02C LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (INDIA) D684-00-0479-07 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0479-08 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES (TURKEY) D684-00-0479-09 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0479-10 LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, US ONLY D684-00-0479-01U LINEAR 7.5Fr. 34cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0479-02U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES D684-00-0480-01 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA) D684-00-0480-02 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (CHINA) D684-00-0480-01C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(CHINA) D684-00-0480-02C LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (INDIA) D684-00-0480-07 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (APA)(INDIA) D684-00-0480-08 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES (TURKEY) D684-00-0480-09 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0480-10 LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, US ONLY D684-00-0480-01U LINEAR 7.5Fr. 40cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0480-02U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES D684-00-0478-01 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) D684-00-0478-02 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (CHINA) D684-00-0478-01C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (CHINA) D684-00-0478-02C LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (INDIA) D684-00-0478-07 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0478-08 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (TURKEY) D684-00-0478-09 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0478-10 LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES, US ONLY D684-00-0478-01U LINEAR 7.5Fr. 25cc IAB WITH ACCESSORIES (APA) US ONLY D684-00-0478-02U PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 25 cc IABs D884-00-0019-12 PACKAGED INSERTION KIT - LINEAR 7.5 Fr. 34/40 cc IABs D884-00-0019-13
• MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D684-00-0296-01 MEGA 8Fr. 50cc IAB WITH STATLOCK & APA D684-00-0296-02 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (W/O STATLOCK) D684-00-0296-03 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (TURKEY) D684-00-0296-09 MEGA 8Fr. 50cc IAB WITH ACCESSORIES WITH APA (TURKEY) D684-00-0296-10 MEGA 8Fr. 50cc IAB WITH ACCESSORIES, US ONLY D684-00-0296-01U MEGA 8Fr. 50cc IAB WITH ACCESSORIES, (APA) US ONLY D684-00-0296-02U MEGA 8Fr. 50cc IAB WITH ACCESSORIES (CHINA) D684-00-0498-01 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (INDIA) D684-00-0498-07 MEGA 8Fr. 50cc IAB WITH ACCESSORIES (APA) (INDIA) D684-00-0498-08 PACKAGED INSERTION KIT - MEGA 8 Fr. 50 cc IAB D884-00-0019-17
• 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-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
• 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-UC-0800-83, 0998-UC-0800-85.
• 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-UC-0800-83, 0998-UC-0800-85,
• Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0800-35, D998-00-0800-36, D998-00-0800-45, D998-00-0800-52, D998-00-0800-53, D998-00-0800-55, D998-00-0800-65, D998-00-0800-83, D998-UC-0800-31, D998-UC-0800-33, D998-UC-0800-52, D998-UC-0800-53, D998-UC-0800-55.
• 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-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65, 0998-00-0800-36, 0998-UC-0800-32, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-65,
• 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, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.
• Cardiosave Rescue. Model Number: 0998-00-0800-83.