The Recall Desk

Manufacturer

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

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

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.

51–75 of 138

  • SevereFDA (Devices)·Z-1735-2023·2023-06-28

    Implantable defibrillators risk energy output failure during high voltage therapy

    Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.

    Product
    CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1726-2023·2023-06-28

    Medtronic ICD COBALT DR Potential Reduced Energy Output During Therapy

    Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.

    Product
    ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1713-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy

    Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may experience reduced or no energy output during high-voltage therapy, potentially preventing treatment of life-threatening heart rhythms.

    Product
    ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1720-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected worldwide.

    Product
    ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1751-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling 1,754 CRT-D and ICD implantable defibrillators with a specific feedthrough component that may not deliver therapy when needed. Devices were distributed nationwide and worldwide.

    Product
    CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1806-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design defect.

    Product
    ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1808-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail During High Voltage Therapy

    Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a defect in the electrical feedthrough. The devices risk reduced or no energy output during high-voltage treatment.

    Product
    ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1807-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy

    Medtronic recalls approximately 5,622 implantable cardioverter defibrillators that may produce reduced or no energy output during high-voltage therapy due to a specific feedthrough component defect.

    Product
    ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1822-2023·2023-06-28

    Implantable Heart Defibrillators May Fail to Deliver Therapy

    Medtronic implantable heart defibrillators may fail to deliver therapy during emergencies. The rare defect affects 510 devices distributed nationwide and worldwide.

    Product
    ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1772-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough design issue. This could prevent life-saving electrical therapy from being delivered.

    Product
    CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1748-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Therapy During Critical Events

    Certain Medtronic implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough manufacturing defect. 523 units distributed worldwide are affected.

    Product
    CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1789-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic implantable defibrillators with certain feedthroughs may fail to deliver high-voltage therapy when needed. This rare malfunction could prevent life-saving electrical treatment.

    Product
    ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1749-2023·2023-06-28

    Implantable Cardiac Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Certain Medtronic implantable cardiac defibrillators with specific glassed feedthrough components may deliver reduced energy during high-voltage therapy. This could prevent the device from functioning when needed in cardiac emergencies.

    Product
    CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1794-2023·2023-06-28

    FDA Recalls Medtronic Implantable Defibrillators Due to Potential Output Risk

    Medtronic's ICD-VR VISIA AF S implantable defibrillators may fail to deliver energy during high-voltage therapy due to a feedthrough component defect. The FDA Class I recall affects 194 units distributed nationwide and worldwide.

    Product
    ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1717-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Reduced or No Therapy Output

    Certain Medtronic implantable cardioverter defibrillators and cardiac resynchronization defibrillators may fail to deliver energy during high-voltage therapy due to a specific feedthrough design issue. The recall affects 3,801 units distributed in the US and worldwide.

    Product
    ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1785-2023·2023-06-28

    Medtronic implantable defibrillators recalled for potential therapy delivery failure

    Medtronic has recalled certain implantable cardioverter defibrillators due to a rare risk of reduced or no energy output during high-voltage therapy.

    Product
    CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1773-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Critical Therapy

    Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.

    Product
    CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1724-2023·2023-06-28

    Medtronic ICD Devices Potential Energy Output Failure During Therapy

    Medtronic's implantable cardioverter defibrillators (ICDs) may produce reduced or no energy output during high voltage therapy due to a feedthrough defect. Patients with affected lot numbers should contact their healthcare provider.

    Product
    ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1816-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic recalls certain ICD and CRT-D defibrillators due to a rare potential for reduced or no-energy output during high-voltage therapy. Affected devices were manufactured with a specific glassed feedthrough component.

    Product
    ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2023·2023-06-28

    Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic's ICD-VR DVME3D4 defibrillators are recalled due to a rare risk of reduced or no energy output during high-voltage therapy. The defect involves a specific feedthrough component and affects approximately 14,989 units distributed nationwide and worldwide.

    Product
    ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail To Deliver Therapy; Class I Recall

    Medtronic implantable cardioverter defibrillators (ICDs) may fail to deliver high-voltage therapy due to a manufacturing defect in a specific feedthrough component. 447 units are affected worldwide.

    Product
    ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2023·2023-06-28

    Medtronic Implantable Defibrillators Recall Due to Potential Therapy Failure

    Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to a rare potential for reduced or no-energy output during high voltage therapy. The recalled devices contain a specific feedthrough component.

    Product
    CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1711-2023·2023-06-28

    Medtronic Cardiac Defibrillators May Fail to Deliver Therapy

    Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may produce reduced or no energy output during high voltage therapy due to a defective feedthrough component.

    Product
    ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1781-2023·2023-06-28

    Implantable Cardiac Devices Risk Therapy Failure From Feedthrough Defect

    Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a defective feedthrough component. The FDA classified this as a Class I recall affecting 2,884 devices.

    Product
    CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1793-2023·2023-06-28

    Implantable Defibrillators May Produce Reduced or No Energy Output

    Medtronic implantable cardioverter defibrillators may produce reduced or no-energy output during high voltage therapy due to a defective feedthrough component. The defect affects 176 units distributed worldwide.

    Product
    ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide