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.

51–75 of 82

SevereFDA (Devices)·Z-1765-2023·2023-06-28
Implantable Defibrillators Recalled: Potential Therapy Energy Delivery Failure
Medtronic is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may deliver reduced or no energy during high-voltage therapy. The recall affects approximately 6,536 units with a specific feedthrough component.
Product
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; 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-1706-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Failure During High-Voltage Treatment
Medtronic is recalling specific Implantable Cardioverter Defibrillator (ICD) models due to a rare potential for reduced or no energy output during high-voltage therapy. The issue is related to a specific manufacturing defect in the device feedthrough.
Product
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; 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
SevereFDA (Devices)·Z-1715-2023·2023-06-28
Medtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling approximately 10,900 ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a feedthrough component defect. No illnesses reported, but the rare defect poses risk of inadequate device function during critical treatment.
Product
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1722-2023·2023-06-28
Implantable cardioverter defibrillators recalled for potential therapy delivery failure
Medtronic implantable cardioverter defibrillators (ICDs) with a specific glassed feedthrough are recalled due to a rare potential for reduced or no energy output during high voltage therapy.
Product
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1757-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
3,570 implantable cardioverter defibrillators and cardiac resynchronization defibrillators with a specific feedthrough defect may fail to deliver high-voltage therapy when needed.
Product
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; 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-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-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-1708-2023·2023-06-28
Implantable Cardioverter Defibrillators with defective feedthrough may fail therapy delivery
Medtronic's EVERA XT implantable cardioverter defibrillators may fail to deliver therapy due to a rare feedthrough defect affecting 727 units worldwide.
Product
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; 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-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-1705-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Reduced Energy Output During Therapy
Medtronic is recalling 522 implantable cardioverter defibrillators that may deliver reduced or no energy during high-voltage therapy due to a feedthrough defect.
Product
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; 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-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-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-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-1815-2023·2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail During Critical Therapy
Medtronic is recalling 14,270 implantable cardioverter defibrillators with a specific feedthrough that may produce reduced or no energy output during high-voltage therapy. The affected devices may fail to deliver critical treatment when needed.
Product
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2023·2023-06-28
Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
Product
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (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
HighFDA (Devices)·Z-1312-2023·2023-04-05
Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk
Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.
Product
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1487-2022·2022-08-17
Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2073-2019·2019-08-14
St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators
St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.
Product
ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2075-2019·2019-08-14
St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators
St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Product
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
Category
Medical Device
Distribution
Distributed nationwide