Datascope Corporation
Fairfield, NJ
This page shows every FDA and USDA recall linked to Datascope Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
75
Total Recalls
2007
First Recall
2022
Most Recent
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Oct 24, 2022
· Device
Open, Classified
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Sep 8, 2022
· Device
Open, Classified
Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Sep 8, 2022
· Device
Open, Classified
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Sep 8, 2022
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Produc...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-0...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB,
P/N: 0684-00-0294-01,0684-00-0294-01U,...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - P...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 -...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - P...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 -...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit
P/N: 0684-00-0478-01, 0684-00-0478-...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,06...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 -...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB
Kit P/N: 0684-00-0480-01, 0684-00-0480-0...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-0...
Aug 21, 2020
· Device
Open, Classified
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For...
Aug 21, 2020
· Device
Open, Classified
Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percuta...
Nov 20, 2019
· Device
Terminated
Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for per...
Nov 20, 2019
· Device
Terminated
Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percu...
Nov 20, 2019
· Device
Terminated
Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01
Produc...
May 28, 2019
· Device
Terminated
Intra-Aortic Balloon Catheter Mega 8FR 50cc
Product Usage:
The intra-aortic balloon catheter and accessories a...
Apr 16, 2018
· Device
Terminated
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc
Product Usage:
The intra-aortic balloon catheter and accessorie...
Apr 16, 2018
· Device
Terminated
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc
Product Usage:
The intra-aortic balloon catheter and accessorie...
Apr 16, 2018
· Device
Terminated
BEQ-TOP 50903 Custom ECC Pack-Pedriatric
, Custom Tubing Kit, Catalog No. 709000078
Oct 19, 2017
· Device
Terminated
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
Oct 19, 2017
· Device
Terminated
BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
Oct 19, 2017
· Device
Terminated
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
Oct 19, 2017
· Device
Terminated
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
Oct 19, 2017
· Device
Terminated
BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
Oct 19, 2017
· Device
Terminated
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
Oct 19, 2017
· Device
Terminated
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
Oct 19, 2017
· Device
Terminated
BEQ-TOP 22701, Catalog No. 701050790
Oct 19, 2017
· Device
Terminated
NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
Oct 19, 2017
· Device
Terminated
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
Oct 19, 2017
· Device
Terminated
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
Oct 19, 2017
· Device
Terminated
BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370
Oct 19, 2017
· Device
Terminated
BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
Oct 19, 2017
· Device
Terminated
BEQ-T 25502 1/4 Better Bladder
, Custom Tubing Kit, Catalog No. 709000434
Oct 19, 2017
· Device
Terminated
BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
Oct 19, 2017
· Device
Terminated
BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
Oct 19, 2017
· Device
Terminated
BEQ-TOP 5210 ECC Set -
Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
Oct 19, 2017
· Device
Terminated
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
Oct 19, 2017
· Device
Terminated
BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
Oct 19, 2017
· Device
Terminated
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
Oct 19, 2017
· Device
Terminated
BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
Oct 19, 2017
· Device
Terminated