The Recall Desk

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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

What the numbers show

Total
198
Critical
8
Severe
126
Most recent
2023-06-28

Of the 198 recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) we have scored against our rubric, 8 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 126 (64%) 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.

176–198 of 198

  • ModerateFDA (Devices)·Z-0796-2019·2019-02-13

    Medtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions

    Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.

    Product
    MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0795-2019·2019-02-13

    Medtronic CareLink 2090 Programmer Recalled for Longevity Display Error

    Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.

    Product
    MEDTRONIC CARELINK 2090 programmer
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0406-2019·2018-11-14

    Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability

    Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.

    Product
    Medtronic CareLink 2090 Programmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2419-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,821 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular def
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2418-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 3 EnTrust ICDs because they may lose high voltage therapy near battery end-of-life without prior warning.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular def
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2420-2018·2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling EnTrust Escudo ICDs due to a potential loss of high voltage and anti-tachycardia pacing therapy as the battery nears its end of life.

    Product
    Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2417-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,890 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    Product
    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a potential device reset caused by a timing interaction between specific diagnostic and pacing features.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradyc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2413-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Devices Recalled for Potential Reset

    Medtronic is recalling Percepta CRT-P MRI SureScan devices due to a timing interaction that may cause a device reset.

    Product
    Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradyc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2416-2018·2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.

    Product
    Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2414-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,604 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2412-2018·2018-07-18

    Medtronic Percepta CRT-P MRI SureScan Recall for Device Reset Risk

    Medtronic is recalling 1,842 Percepta CRT-P MRI SureScan implantable pulse generators due to a potential device reset caused by a timing interaction between diagnostic and pacing features.

    Product
    Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2421-2018·2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.

    Product
    Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2317-2018·2018-07-04

    Medtronic Model 53401 Pacemakers Recalled for Unexpected Power Reset

    Medtronic is recalling 1,108 Model 53401 temporary external pacemakers because they may revert to nominal settings during use due to an unexpected power on reset.

    Product
    Single Chamber Temporary External Pacemaker, Model 53401
    Category
    Medical Device
    Distribution
    45 states
  • CriticalFDA (Devices)·Z-0587-2018·2018-02-28

    Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention

    Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0583-2018·2018-02-28

    Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0586-2018·2018-02-28

    Medtronic Recalls Claria MRI CRT-Ds Due to Therapy Prevention Risk

    Medtronic is recalling 951 Claria MRI CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0589-2018·2018-02-28

    Medtronic Visia AF ICDs Recalled for Potential Therapy Failure

    Medtronic is recalling 951 Visia AF ICDs and CRT-Ds because they may fail to deliver high or low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable devices that automatically detect and treat episodes of ventricular fibrillation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0582-2018·2018-02-28

    Medtronic Recalls Amplia MRI CRT-D Devices Due to Therapy Prevention Risk

    Medtronic is recalling 951 Amplia MRI CRT-D devices because they may fail to deliver high or low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Am
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2018·2018-02-28

    Medtronic Recalls 951 Evera MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Evera MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy. Patients should contact their healthcare provider.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Produ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0588-2018·2018-02-28

    Medtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk

    Medtronic is recalling 951 Visia AF MRI ICDs and CRT-Ds because a defect may prevent high and low voltage therapy.

    Product
    Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No. DVFB1D4); EXPANSION: c. Visia AF MRI S VR SureScan ICD DF1 (Product No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2018·2018-02-28

    Medtronic Viva CRT-D Recall for Possible Prevention of Therapy

    Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No. DT
    Category
    Medical Device
    Distribution
    Distributed nationwide