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
71
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 71 (87%) 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.

1–25 of 82

  • HighFDA (Devices)·Z-1068-2025·2025-02-05

    Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy

    LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.

    Product
    Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2025·2024-12-04

    V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures

    KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.

    Product
    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2024·2024-05-01

    Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure

    EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.

    Product
    20" Lead Wires, Replacement Part Number: 1067724-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2024·2024-02-28

    OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy

    The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.

    Product
    OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0693-2024·2024-01-24

    Percussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled

    Percussionaire Corporation recalled 195 Distal Phasitron devices after finding the breathing circuit reservoir bag may be assembled at the wrong attachment point, potentially affecting therapy delivery.

    Product
    Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1719-2023·2023-06-28

    Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

    Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.

    Product
    ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1755-2023·2023-06-28

    Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect

    Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.

    Product
    CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1738-2023·2023-06-28

    Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy

    Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.

    Product
    CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1766-2023·2023-06-28

    Implantable defibrillators may deliver reduced or no energy during therapy

    Medtronic implantable defibrillators and cardiac resynchronization devices with a specific glassed feedthrough may fail to deliver full energy during therapy. Approximately 8,575 units affected worldwide.

    Product
    CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1796-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

    Medtronic recalls implantable cardioverter defibrillators due to rare potential for reduced or no-energy output during high-voltage therapy, which could prevent life-saving defibrillation.

    Product
    ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1771-2023·2023-06-28

    Medtronic implantable defibrillators may fail to deliver therapy

    Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.

    Product
    CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1792-2023·2023-06-28

    Medtronic ICD defibrillators may fail to deliver critical therapy

    Medtronic recalled certain implantable defibrillators that may fail to deliver electrical therapy during critical heart rhythm events due to a manufacturing defect in the device feedthrough.

    Product
    ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; 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-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-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-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-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-1799-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure

    Medtronic's implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a feedthrough defect. Approximately 6,821 devices are affected worldwide.

    Product
    ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1803-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure

    Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 units distributed nationwide and worldwide.

    Product
    ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1727-2023·2023-06-28

    Implantable cardioverter defibrillators may output reduced or no energy during therapy

    Medtronic ICDs and CRT-Ds with specific feedthroughs may fail to deliver adequate high-voltage therapy. This FDA Class I recall affects 487 units distributed nationwide and worldwide.

    Product
    ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1740-2023·2023-06-28

    Implantable Defibrillators Risk Loss of Therapy from Feedthrough Defect

    Medtronic recalls certain CRT-D VIVA QUAD XT GOLD implantable defibrillators due to a rare risk of reduced or no electrical output during therapy. Affected devices contain a specific glassed feedthrough component.

    Product
    CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1710-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy

    Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.

    Product
    ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1774-2023·2023-06-28

    Implantable Cardioverter Defibrillators May Fail During High-Voltage Therapy

    Some Medtronic implantable defibrillators contain a specific feedthrough that may rarely cause reduced or no energy output during high-voltage therapy. The recall affects approximately 4,151 units distributed nationwide.

    Product
    CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1753-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy

    Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.

    Product
    CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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