PlainRecalls

Medtronic Inc.

67 recalls on record · Latest: Dec 10, 2025

Medtronic Inc. Recall Insight

Medtronic Inc. appears on 67 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.080% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 10, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 17 entries, severity tagging shows 2 critical, 15 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 16 of 17 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (17). The date window on this page runs from Dec 9, 2015 to Feb 19, 2020.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Critical Feb 19, 2020

Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-15…

FDA Devices Moderate Jul 3, 2019

Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

FDA Devices Moderate Jul 3, 2019

Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

FDA Devices Moderate Jul 3, 2019

Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

FDA Devices Moderate May 15, 2019

Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.

FDA Devices Moderate Sep 26, 2018

Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose …

FDA Devices Moderate Jul 11, 2018

Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754

FDA Devices Critical Apr 4, 2018

6F Taiga Guiding Catheter

FDA Devices Moderate Dec 6, 2017

Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo …

FDA Devices Moderate Nov 29, 2017

Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)

FDA Devices Moderate Jun 28, 2017

MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.

FDA Devices Moderate Jun 28, 2017

MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.

FDA Devices Moderate Jun 28, 2017

MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.

FDA Devices Moderate Dec 28, 2016

Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fu…

FDA Devices Moderate Oct 5, 2016

CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retr…

FDA Devices Moderate Apr 6, 2016

Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.

FDA Devices Moderate Dec 9, 2015

Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds