Hazard

Therapy Delivery Failure recalls

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

What the numbers show

Total: 16
Critical: 2
Severe: 11
Most recent: 2026-05-13

Of the 16 therapy delivery failure recalls we have scored against our rubric, 2 (13%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (69%) 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 delivery 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.

1–16 of 16

HighFDA (Devices)·Z-2065-2026·2026-05-13
Physio-Control Defibrillators May Lack Required Performance Inspection
Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.
Product
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-00193
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1742-2023·2023-06-28
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Product
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1769-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.
Product
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1791-2023·2023-06-28
Implantable Defibrillators With Defective Feedthrough May Fail to Deliver Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component affecting 71 units.
Product
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; 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-1737-2023·2023-06-28
Medtronic Implantable Heart Defibrillators Risk Therapy Delivery Failure
Medtronic CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.
Product
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1814-2023·2023-06-28
Medtronic ICD-VR PRIMO MRI Defibrillators: Potential Therapy Delivery Failure
Certain Medtronic implantable cardioverter defibrillators and CRT-Ds may fail to deliver adequate energy during high-voltage therapy due to a feedthrough component defect. This affects 5,215 units distributed worldwide.
Product
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; 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-1747-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 7 implantable cardioverter-defibrillators that may fail to deliver electrical therapy during critical heart rhythms. The defect affects devices with a specific feedthrough component.
Product
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1813-2023·2023-06-28
Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable defibrillators may fail to deliver therapy during critical cardiac events due to a feedthrough defect. Approximately 25,058 units are affected nationwide and worldwide.
Product
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1746-2023·2023-06-28
Medtronic Implantable Cardiac Defibrillators Risk Therapy Delivery Failure
Medtronic is recalling certain CRT-D and ICD models due to a potential feedthrough defect that may prevent energy delivery during high-voltage therapy. The FDA Class I recall affects 435 units distributed in the United States and worldwide.
Product
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; 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-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-1804-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Failure to Deliver Therapy
Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.
Product
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2023·2023-06-28
Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
Product
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2023·2023-06-28
Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.
Product
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide