Brand

Datascope Corporation Recalls

52 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Datascope Corporation.

52Total Recalls
0Critical
309,016Units Affected
Aug 5, 2022Most Recent
All Recalls

Every Datascope Corporation Recall

Sorted by most recent. Click any recall for full details.

52 recalls
High RiskFDA
Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Surgical Devices·4,414 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
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, 0684-0...
Cardiac Devices·54,816 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndr...
Cardiac Devices·3,059 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications F...
Cardiac Devices·12,032 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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...
Cardiac Devices·31,529 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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, 0...
Cardiac Devices·69,278 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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 068...
Cardiac Devices·1,746 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications...
Cardiac Devices·3,542 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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, 0684-00-02...
Cardiac Devices·1,275 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications...
Cardiac Devices·3,055 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For U...
Cardiac Devices·2,550 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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-...
Cardiac Devices·16,104 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications...
Cardiac Devices·6,111 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
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...
Cardiac Devices·29,653 affected·Jul 27, 2020
High RiskFDA
Datascope Corporation
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET I...
Surgical Devices·523 affected·Nov 20, 2019
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·655 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide co...
Cardiac Devices·2,714 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counte...
Cardiac Devices·12,744 affected·Feb 21, 2018
High RiskFDA
Datascope Corporation
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
Medical Devices·1 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Medical Devices·3 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Medical Devices·9 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Medical Devices·1 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
Medical Devices·22 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Medical Devices·3 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Medical Devices·11 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Respiratory Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Respiratory Devices·18 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 22701, Catalog No. 701050790
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Medical Devices·9 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
Medical Devices·40 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Medical Devices·3 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Medical Devices·10 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Medical Devices·18 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Medical Devices·6 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Medical Devices·18 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
Medical Devices·9 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
Medical Devices·4 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02
Medical Devices·10 affected·Oct 19, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmona...
Respiratory Devices·10 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiop...
Respiratory Devices·27 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulm...
Respiratory Devices·8 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a c...
Cardiac Devices·996 affected·Apr 12, 2017
High RiskFDA
Datascope Corporation
Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 Part Number: 709000058 The HLM Tubing Sets with Bioline Coating are...
Cardiac Devices·21 affected·Feb 16, 2017