Maquet Datascope Corp - Cardiac Assist Division

Complete recall history across all FDA and CPSC categories — 14 total recalls

Maquet Datascope Corp - Cardiac Assist Division 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 (14)

FDA medical device enforcement actions by Maquet Datascope Corp - Cardiac Assist Division

Date Product Reason Class
Sep 20, 2018 Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 There is a potential for interruption and/or inability to start therapy to th... Class I
Sep 20, 2018 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 There is a potential for interruption and/or inability to start therapy to th... Class I
May 3, 2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... Ingress of fluids into the device can affect various electronic circuit board... Class I
Jul 17, 2017 CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affe... Class I
Jul 17, 2017 CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... False blood back detection alarm and the ingress of fluids into the IABP affe... Class I
Jul 17, 2017 CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affe... Class I
Jun 16, 2017 CS 100 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power u... Class I
Jun 16, 2017 CS 100i Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power u... Class I
Jun 16, 2017 CS 300 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power u... Class I
Dec 23, 2016 CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09... Maquet has received 3 confirmed complaints related to the Li-lon Battery used... Class II
Dec 16, 2015 Cardiosave Hybrid and rescue IABP Maquet has recieved information that in some Cardiosave IABPS, the scroll com... Class II
Jan 30, 2015 Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Power supply malfunction complaints related to suboptimal thermal management. Class II
Dec 16, 2014 CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and... Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus ... Class II
Mar 21, 2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.... Potential mechanical failure of the fan assembly associated with the power su... Class I

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.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.