Medtronic Inc

Complete recall history across all FDA and CPSC categories — 17 total recalls

Medtronic 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 (17)

FDA medical device enforcement actions by Medtronic Inc

Date Product Reason Class
Dec 4, 2025 Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210... Stents may be impacted by a Nitinol anomaly which causes a reduced stent diam... Class II
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and ... Class II
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and ... Class II
Oct 12, 2023 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and ... Class II
Jun 24, 2022 Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wi... Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct dia... Class II
May 5, 2022 HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular As... Batteries for the HVAD system have a weld defect affecting internal component... Class I
Apr 14, 2022 HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1... The pump may have a welding defect that can lead the pump to malfunction. The... Class I
Mar 30, 2022 Instructions for Use, Patient Manuals, and Emergency Responder Guides for Hea... Errors and inconsistencies that were identified in the Instruction for Use (I... Class II
Mar 2, 2022 Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonar... There is potential for the capsule bond to break during the procedure. Class I
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... Fifteen affected devices were distributed worldwide, which were mislabeled wi... Class II
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... Fifteen affected devices were distributed worldwide, which were mislabeled wi... Class II
May 21, 2019 Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... Fifteen affected devices were distributed worldwide, which were mislabeled wi... Class II
May 21, 2019 Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... Fifteen affected devices were distributed worldwide, which were mislabeled wi... Class II
May 21, 2019 Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... Fifteen affected devices were distributed worldwide, which were mislabeled wi... Class II
Sep 26, 2017 6F Taiga Guiding Catheter Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitt... Class I
Nov 16, 2016 Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion... Medtronic is initiating a voluntary product recall for specific lot numbers o... Class II
Nov 10, 2016 ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross... Medtronic identified an issue with specific models and lots of the PowerCross... 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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