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Medtronic Cardiovascular Surgery-the Heart Valve Division

Complete recall history across all FDA and CPSC categories — 4 total recalls

Medtronic Cardiovascular Surgery-the Heart Valve 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 (4)

FDA medical device enforcement actions by Medtronic Cardiovascular Surgery-the Heart Valve Division

Date Product Reason Class
Aug 3, 2016 Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-... Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery ... Class II
Jul 15, 2015 EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... Medtronic is recalling the EnVeo R Loading Systems because of the presence of... Class I
Aug 15, 2014 Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174A... Medtronic has decided to discontinue production and distribution of this low-... Class II
Jan 9, 2014 Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obtura... Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model... Class II

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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