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Medtronic Ats Medical, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Medtronic Ats Medical, Inc. 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 (5)

FDA medical device enforcement actions by Medtronic Ats Medical, Inc.

Date Product Reason Class
Oct 12, 2020 Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF... There is a potential defect in the seals of the sterile barrier pouch used to... Class II
Oct 12, 2020 Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF... There is a potential defect in the seals of the sterile barrier pouch used to... Class II
Oct 12, 2020 Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM... There is a potential defect in the seals of the sterile barrier pouch used to... Class II
Oct 12, 2020 Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF... There is a potential defect in the seals of the sterile barrier pouch used to... Class II
Feb 11, 2020 Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm Medtronic received a complaint from China that the label on the box for an Op... 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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