The Recall Desk

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure

9 recalls in our database name Medtronic Inc., Cardiac Rhythm and Heart Failure as the manufacturing or recalling firm.

What the numbers show

Total
9
Critical
0
Severe
2
Most recent
2018-01-31

Of the 9 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (22%) 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.

1–9 of 9

  • HighFDA (Devices)·Z-0399-2018·2018-01-31

    Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.

    Product
    MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0400-2018·2018-01-31

    Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues

    Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.

    Product
    MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2117-2017·2017-05-31

    Medtronic Recalls MRI-Conditional Cardiac Resynchronization Therapy Devices

    Medtronic is recalling specific MRI-conditional CRT-D devices due to an unexpected transient mode switch behavior detected during systems testing.

    Product
    Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2017·2017-01-18

    Medtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error

    Medtronic is recalling 21,111 MRI-conditional cardiac resynchronization therapy devices because the AdaptivCRT feature may appear enabled when it is not active.

    Product
    Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular t
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2650-2016·2016-08-31

    Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators

    Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.

    Product
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2651-2016·2016-08-31

    Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk

    Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.

    Product
    Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardiov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2016·2016-07-20

    Medtronic Temporary Pacing Lead System Recalled for Design Non-Compliance

    Medtronic is recalling Temporary Pacing Lead Systems because they do not meet design standards preventing connection to hazardous voltage.

    Product
    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is dispos
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2016·2016-07-13

    Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure

    Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.

    Product
    Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1605-2016·2016-05-11

    Medtronic CareLink Monitors Recalled for Firmware Dial-Up Configuration Error

    Medtronic is recalling CareLink and CareLink Express monitors because a firmware update contained incorrect dial-up configuration data, potentially preventing data transmission to the CareLink Network.

    Product
    Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s CareLi
    Category
    Medical Device
    Distribution
    0 states