Datascope Corporation

Complete recall history across all FDA and CPSC categories — 67 total recalls

Datascope Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (67)

FDA medical device enforcement actions by Datascope Corporation. Showing most recent 50.

Date Product Reason Class
Aug 5, 2022 Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II
Aug 5, 2022 Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II
Aug 5, 2022 MEGA 8Fr 50cc Intra-Aortic Balloon Catheter Certain lots containing undersized dilator. Class II
Aug 5, 2022 LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. in... The balloon volume is incorrectly described as 34cc instead of 40cc on one of... Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB ... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: ... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan)... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Ki... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 068... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB ... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan)... Potential Endotoxin Contamination Class II
Jul 27, 2020 Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N:... Potential Endotoxin Contamination Class II
Nov 20, 2019 Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is ... Potential for compromised sterility in breached pouches of specific lots of R... Class II
Nov 20, 2019 Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It i... Potential for compromised sterility in breached pouches of specific lots of R... Class II
Nov 20, 2019 Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an... Potential for compromised sterility in breached pouches of specific lots of R... Class II
May 28, 2019 Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Pa... The device was distributed with the outer carton labeled with the manufacture... Class II
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Cathete... Class II
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-ao... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Cathete... Class II
Feb 21, 2018 Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-ao... The U.S. Instructions For Use for the Mega Intra-Aortic Balloon (IAB) Cathete... Class II
Oct 19, 2017 BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 70... The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 50903 Custom ECC Pack-Pedriatric , Custom Tubing Kit, Catalog No. 70... The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 8504 1/4X1/4 PACK W/QP, Custom Tubing Kit, Catalog No. 701066949R02 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067... The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 22701, Catalog No. 701050790 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604 The Better Bladder device provided as part of some custom tubing kits has bee... Class II
Oct 19, 2017 BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874 The Better Bladder device provided as part of some custom tubing kits has bee... Class II

View all 67 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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