Datascope Corporation
53 recalls on record · Latest: Nov 2, 2022
FDA Devices Moderate Nov 2, 2022
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
FDA Devices Moderate Sep 14, 2022
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 14, 2022
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 14, 2022
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 2, 2020
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, 0…
FDA Devices Moderate Sep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac …
FDA Devices Moderate Sep 2, 2020
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: Acu…
FDA Devices Moderate Sep 2, 2020
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, 0684-0…
FDA Devices Moderate Sep 2, 2020
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-…
FDA Devices Moderate Sep 2, 2020
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…
FDA Devices Moderate Sep 2, 2020
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: A…
FDA Devices Moderate Sep 2, 2020
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- Prod…
FDA Devices Moderate Sep 2, 2020
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: A…
FDA Devices Moderate Sep 2, 2020
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 Co…
FDA Devices Moderate Sep 2, 2020
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, 06…
FDA Devices Moderate Sep 2, 2020
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: A…
FDA Devices Moderate Sep 2, 2020
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, 0684-00-05…
FDA Devices Moderate Feb 12, 2020
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic B…
FDA Devices Moderate Jun 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Cu…
FDA Devices Moderate Jun 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Byp…
FDA Devices Moderate Jun 20, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass…
FDA Devices Low Jun 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Devices Low Jun 13, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Devices Moderate May 16, 2018
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
FDA Devices Moderate May 16, 2018
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
FDA Devices Moderate May 16, 2018
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
FDA Devices Moderate May 16, 2018
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
FDA Devices Moderate May 16, 2018
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
FDA Devices Moderate May 16, 2018
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Devices Moderate May 16, 2018
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
FDA Devices Moderate May 16, 2018
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
FDA Devices Moderate May 16, 2018
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
FDA Devices Moderate May 16, 2018
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
FDA Devices Moderate May 16, 2018
BEQ-TOP 22701, Catalog No. 701050790
FDA Devices Moderate May 16, 2018
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
FDA Devices Moderate May 16, 2018
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
FDA Devices Moderate May 16, 2018
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
FDA Devices Moderate May 16, 2018
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
FDA Devices Moderate May 16, 2018
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
FDA Devices Moderate May 16, 2018
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
FDA Devices Moderate May 16, 2018
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
FDA Devices Moderate May 16, 2018
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
FDA Devices Moderate May 16, 2018
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Devices Moderate May 16, 2018
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
FDA Devices Moderate May 16, 2018
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
FDA Devices Moderate May 16, 2018
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
FDA Devices Moderate Apr 25, 2018
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsat…
FDA Devices Moderate Apr 25, 2018
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsat…
FDA Devices Moderate Apr 25, 2018
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation …
FDA Devices Moderate May 31, 2017