The Recall Desk

Manufacturer

Medtronic, Inc.

109 recalls in our database name Medtronic, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
109
Critical
0
Severe
8
Most recent
2026-05-06

Of the 109 recalls from Medtronic, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 109

  • SevereFDA (Devices)·Z-0958-2020·2020-02-19

    Medtronic MiniMed 640G Insulin Pump Recall for Loose Reservoir Risk

    Medtronic is recalling specific 640G insulin pumps due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0957-2020·2020-02-19

    Medtronic MiniMed 620G Insulin Pump Recall for Loose Reservoirs

    Medtronic is recalling MiniMed 620G insulin pumps not distributed in the US due to a loose reservoir that may cause incorrect insulin delivery.

    Product
    Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0956-2020·2020-02-19

    Medtronic MiniMed 670G System Recalled for Loose Insulin Reservoir

    Medtronic is recalling MiniMed 670G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    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-1582, MMT-1780, MMT-1781, and MMT-1782
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0955-2020·2020-02-19

    Medtronic MiniMed 630G System Recalled for Loose Reservoir Defect

    Medtronic is recalling MiniMed 630G Systems with SmartGuard because a broken or missing retainer ring can cause the insulin reservoir to become loose, leading to incorrect insulin delivery.

    Product
    Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0177-2020·2019-11-13

    Medtronic Recalls MiniMed Model 500 Remote Controls for Security Vulnerability

    Medtronic is recalling MiniMed Model 500 Remote Controls used with the MiniMed 508 Insulin Pump due to a potential security vulnerability.

    Product
    Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2020·2019-11-13

    Medtronic Recalls MiniMed Remote Transmitters for Security Vulnerability

    Medtronic is recalling MiniMed Model 503 Remote Transmitters due to a potential security vulnerability affecting insulin pump accessories.

    Product
    Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/715, MMT-512/712, MMT-511)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2019·2019-07-03

    Medtronic Hancock II Mitral Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Mitral Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1282-2019·2019-05-15

    Medtronic Guardian Connect App Recalled for Silent Operating System Shutdowns

    Medtronic is recalling the Guardian Connect App because the operating system may close it without warning, preventing users from receiving critical blood glucose alerts.

    Product
    Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0683-2019·2019-01-02

    Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts

    Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.

    Product
    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-3201-2018·2018-09-26

    Medtronic Recalls Contour Plus Link 2.4 Meters with Incorrect Units

    Medtronic is recalling two Contour Plus Link 2.4 meters distributed in Slovakia that display glucose in mg/dL instead of mmol/L.

    Product
    Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the moni
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2377-2018·2018-07-11

    Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for Arabic Translation Error

    Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.

    Product
    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0670-2018·2018-02-28

    Medtronic CareLink iPro Software Recall for Time Conversion Error

    Medtronic is recalling CareLink iPro Therapy Management Software version 1.12 because a time conversion error may cause incorrect reports for data uploaded between September 23 and 27, 2017.

    Product
    Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iP
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0188-2018·2017-12-06

    Medtronic Recalls Everflex Self-Expanding Peripheral Stents Due to Labeling Error

    Medtronic is recalling 21 units of Everflex Self-Expanding Peripheral Stents because the stent length on the label may not match the actual stent length.

    Product
    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0109-2018·2017-11-29

    Medtronic MiniMed Sure-T Infusion Sets Recalled for Insulin Over-Delivery Risk

    Medtronic is recalling Sure-T infusion sets because they may deliver too much insulin. This could cause low blood sugar in patients.

    Product
    Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0110-2018·2017-11-29

    Medtronic MiniMed Mio Infusion Sets Recalled for Potential Insulin Over-Delivery

    Medtronic is recalling MiniMed Mio infusion sets because they may over-deliver insulin. The recall covers 1,513,530 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0108-2018·2017-11-29

    Medtronic MiniMed Silhouette Infusion Sets Recalled for Insulin Over-Delivery Risk

    Medtronic is recalling MiniMed Silhouette infusion sets because they may over-deliver insulin. The recall covers 1,898,570 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0107-2018·2017-11-29

    Medtronic MiniMed Quick-set Infusion Sets Recalled for Insulin Over-delivery Risk

    Medtronic is recalling MiniMed Quick-set infusion sets because they may deliver too much insulin. The recall covers 3,971,030 units distributed worldwide.

    Product
    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2605-2017·2017-06-28

    Medtronic Recalls MiniMed 670G Insulin Pumps Due to Keypad Issues

    Medtronic is recalling 117,239 MiniMed 670G insulin pumps because the keypad may become unresponsive and the pump may become temporarily stuck.

    Product
    MiniMed 670G Insulin Infusion Pump, Catalog No. MMT-1580, MMT-1780, MMT-1782, MMT-1760.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2603-2017·2017-06-28

    Medtronic Recalls MiniMed 630G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 65,959 MiniMed 630G insulin pumps because the device may become temporarily stuck and the keypad may become unresponsive.

    Product
    MiniMed 630G Insulin Infusion Pump, Catalog No. MMT-1715, MMT-1755.
    Category
    Medical Device
    Distribution
    0 states