The Recall Desk

Hazard

Therapy Failure recalls

82 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
82
Critical
3
Severe
74
Most recent
2025-02-05

Of the 82 therapy failure recalls we have scored against our rubric, 3 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 74 (90%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all therapy failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 82

  • 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
  • SevereFDA (Devices)·Z-1723-2023·2023-06-28

    ICD COBALT XT Defibrillators Recalled for Potential Reduced Energy Output

    Medtronic recalled 22,114 ICD COBALT XT defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy delivery caused by a specific feedthrough defect.

    Product
    ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1805-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output

    Medtronic ICDs and CRT-Ds with a specific feedthrough defect may produce reduced or no energy output during high-voltage therapy. The recall involves approximately 4,546 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1707-2023·2023-06-28

    Implantable Defibrillators Risk Reduced or No Energy Output During Therapy

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy due to a feedthrough defect. The FDA Class I recall affects 2,282 units distributed nationwide and worldwide.

    Product
    ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1776-2023·2023-06-28

    Medtronic Implantable Defibrillators May Fail Therapy Energy Delivery

    Medtronic recalls 3 COBALT XT implantable defibrillators that may deliver reduced or no energy during therapy. A defect in the device feedthrough could prevent effective treatment of abnormal heart rhythms.

    Product
    CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1712-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.

    Product
    ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2023·2023-06-28

    Implantable defibrillators may fail to deliver high-voltage therapy due to defect

    Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.

    Product
    ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Reduced Energy Output

    Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a manufacturing issue. The recall affects 1,354 units distributed in the United States and internationally.

    Product
    ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1810-2023·2023-06-28

    Implantable cardioverter defibrillators may fail to deliver therapy

    Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with specific glassed feedthroughs that may deliver reduced or no energy output during high voltage therapy.

    Product
    ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1784-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled Due to Potential Therapy Failure

    Medtronic is recalling approximately 15,427 implantable cardioverter defibrillators with a specific feedthrough due to a rare potential for reduced or no energy output during high voltage therapy. Patients should contact their healthcare provider.

    Product
    CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2023·2023-06-28

    Medtronic CRT-D Defibrillators Recalled for Potential Therapy Output Failure

    Medtronic implantable cardiac defibrillators (CRT-D) may deliver reduced or no energy during critical high-voltage therapy due to a feedthrough defect. The recall affects 193 units that could fail to deliver lifesaving defibrillation shocks when needed.

    Product
    CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1795-2023·2023-06-28

    Implantable Defibrillators May Deliver Reduced or No Energy During Therapy

    Certain Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high voltage therapy. The rare defect affects 16 units distributed nationwide.

    Product
    ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1779-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Critical Heart Therapy

    Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy delivery due to a defective feedthrough component. No injuries have been reported, but patients may not receive proper treatment for life-threatening heart rhythms.

    Product
    CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2023·2023-06-28

    Cardioverter Defibrillators Recalled: Potential Reduced or No-Energy Output

    Certain Medtronic implantable cardioverter defibrillators may fail to deliver proper energy output during high-voltage therapy due to a feedthrough defect. Patients with affected devices should contact Medtronic immediately.

    Product
    CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1768-2023·2023-06-28

    Medtronic Implantable Defibrillators Risk Failure to Deliver High-Voltage Therapy

    Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.

    Product
    CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1762-2023·2023-06-28

    Medtronic Cardiac Defibrillators Potentially Fail to Deliver High-Voltage Therapy

    Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may fail to deliver high-voltage therapy due to a defect in specific glassed feedthrough components. The FDA classified this as a Class I recall due to potential for serious harm.

    Product
    CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1756-2023·2023-06-28

    Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

    Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific feedthrough component.

    Product
    CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1752-2023·2023-06-28

    Medtronic CRT-D BRAVA Implantable Defibrillators—Potential High-Voltage Therapy Failure

    Medtronic implantable cardioverter defibrillators with specific feedthrough components may fail to deliver high-voltage therapy during treatment. Affected units are being recalled due to risk of reduced or absent energy output.

    Product
    CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1780-2023·2023-06-28

    Medtronic ICD COBALT XT implants may deliver reduced or no therapy

    Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.

    Product
    ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1802-2023·2023-06-28

    Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure

    Medtronic is recalling 289 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare potential defect that may prevent proper high-voltage therapy delivery.

    Product
    ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2023·2023-06-28

    ICD defibrillators risk reduced or absent therapy output from feedthrough defect

    Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units nationwide and worldwide.

    Product
    ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide