Datascope Corporation: Medical Device Recalls in 2020

Updated on March 25, 2026.

According to to data from the FDA, there were 20 medical device recalls made by Datascope Corporation in 2020. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.