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.

101–109 of 109

  • HighFDA (Devices)·Z-2604-2017·2017-06-28

    Medtronic Recalls MiniMed 640G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 117,239 MiniMed 640G insulin pumps because the keypad may become unresponsive, potentially preventing users from adjusting insulin delivery.

    Product
    MiniMed 640G Insulin Infusion Pump, Catalog No. MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1551, MMT-1751, MMT-1552, MMT-1752.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2602-2017·2017-06-28

    Medtronic Recalls MiniMed 620G Insulin Pumps Due to Keypad Malfunction

    Medtronic is recalling 6,573 MiniMed 620G insulin infusion pumps because the keypad may become unresponsive and the pump may become temporarily stuck.

    Product
    MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1890-2017·2017-05-10

    Medtronic Recalls MiniMed 620G and 640G Insulin Pumps Due to Software Anomaly

    Medtronic is recalling MiniMed 620G and 640G insulin pumps with software version 2.6 or below because a software anomaly can prevent the internal battery from charging, leading to pump shutdown.

    Product
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0892-2017·2016-12-28

    Medtronic Recalls PowerCross .018 OTW PTA Dilatation Catheters

    Medtronic is recalling 315 units of the PowerCross .018 OTW PTA Dilatation Catheter due to a manufacturing defect causing the balloon to fail to inflate or deflate properly.

    Product
    ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0826-2017·2016-12-28

    Medtronic Recalls Affinity Fusion Oxygenators Due to Plastic Flash Defect

    Medtronic is voluntarily recalling specific lots of Affinity Fusion Oxygenators because of an out-of-specification condition involving additional plastic in the arterial sampling port.

    Product
    Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intend
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2898-2016·2016-10-05

    Medtronic Recalls CareLink iPro Software Due to Time Stamp Error

    Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.

    Product
    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1249-2016·2016-04-06

    Medtronic Recalls Reveal LINQ Cardiac Monitor Due to Algorithm Sensitivity Issue

    Medtronic is recalling Reveal LINQ insertable cardiac monitors because an algorithm issue may trigger replacement alerts prematurely. The device battery and data collection capabilities remain functional.

    Product
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0342-2016·2015-12-09

    Medtronic InSync III Pacemaker Recall for Battery Impedance Issue

    Medtronic is recalling InSync III pacemakers due to unexpected high battery impedance affecting long-term performance.

    Product
    Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2016·2015-11-11

    Medtronic Achieve Electrical Cables Recalled for Potential Sterility Breach

    Medtronic is recalling 64 units of Achieve Electrical Cables (Model 990066) due to a potential sterility breach. The sterile, single-use cables were distributed to facilities in 16 states and DC.

    Product
    Medtronic Achieve Cables, model 990066. The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pac
    Category
    Medical Device
    Distribution
    17 states