Hazard

Defibrillation Failure recalls

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

What the numbers show

Total: 27
Critical: 0
Severe: 17
Most recent: 2024-07-17

Of the 27 defibrillation failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 17 (63%) 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 defibrillation 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 27

HighFDA (Devices)·Z-2324-2024·2024-07-17
ZOLL Powerheart G5 AED shipping film may prevent shock delivery
ZOLL Powerheart G5 AED devices are shipped with a protective film on the front panel. If not removed before use, the film may prevent the shock button from being pressed, delaying or preventing defibrillation therapy.
Product
ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause Sudden Cardiac Arrest (SCA). Model/Catalog Number: G5S-00A G5S-0
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2033-2023·2023-07-12
GE TruSignal Ear Sensor Oximeter Recalled for Defibrillation Energy and Voltage Hazards
GE Healthcare is recalling 708 TruSignal Integrated Ear Sensors (medical-grade pulse oximeters) due to potential defects that could reduce defibrillation energy, cause electrical shock, or produce inaccurate measurements.
Product
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2030-2023·2023-07-12
GE TruSignal Ear Sensor oximeter recalled for electrical and measurement hazards
GE Healthcare is recalling approximately 10,451 TruSignal Ear Sensor oximeters worldwide due to potential electrical hazards and inaccurate measurements that could affect patient safety.
Product
TruSignal Ear Sensor, REF TS-E-D; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2031-2023·2023-07-12
Ear oximeter sensor recalled for defibrillation and voltage safety concerns
GE Healthcare is recalling 512 TruSignal ear oximeter sensors worldwide due to potential defibrillation energy loss, unintended voltage exposure, and measurement inaccuracy risks.
Product
TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2027-2023·2023-07-12
FDA Recalls TruSignal AllFit Oximeter Sensors Worldwide for Device Malfunction
GE Healthcare is recalling 36,337 TruSignal AllFit Sensor oximeters worldwide due to potential defibrillation energy loss, voltage exposure, and measurement errors.
Product
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2029-2023·2023-07-12
TruSignal Wrap Sensor Oximeter Recalled for Defibrillation Failure
GE Healthcare is recalling 5,039 TruSignal Wrap Sensor oximeters due to potential defibrillation energy loss, electrical shock risk, and inaccurate measurements. No illnesses have been reported.
Product
TruSignal Wrap Sensor, REF TS-W-D; Oximeter
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1783-2023·2023-06-28
Implantable Defibrillator Models May Fail to Deliver Shock Therapy
Medtronic implantable cardiac defibrillators may fail to deliver electrical therapy during treatment due to a defective feedthrough component. Approximately 1,878 devices are affected.
Product
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1736-2023·2023-06-28
Medtronic Implantable Defibrillators May Fail to Deliver Therapy
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a rare risk of reduced or no energy output during high voltage therapy.
Product
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1733-2023·2023-06-28
Medtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
Medtronic has recalled 891 implantable cardioverter defibrillators (CRT-D) worldwide due to a rare potential for reduced or absent energy output during defibrillation therapy. Units manufactured with a specific feedthrough component are affected.
Product
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1761-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver Energy During Therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.
Product
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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-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-1819-2023·2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy during treatment
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
Product
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1721-2023·2023-06-28
Implantable Defibrillators May Fail to Deliver High Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators may deliver reduced or no energy during high voltage therapy due to a defective feedthrough. This defect could prevent the device from properly treating life-threatening heart rhythms.
Product
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1741-2023·2023-06-28
Implantable Defibrillator Recall: Risk of Failed High-Voltage Therapy
Medtronic implantable defibrillators may fail to deliver therapy due to a defective feedthrough component. 207 units recalled nationwide and worldwide.
Product
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
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-1489-2022·2022-08-17
Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Product
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1486-2022·2022-08-17
Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.
Product
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0935-2022·2022-04-20
ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation
Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.
Product
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2022·2022-04-20
Cardiac electrode fails electrical safety test; defibrillation may not work
The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.
Product
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2022·2022-04-20
Pre-wired ECG Electrode Set Fails Defibrillation Voltage Safety Standard
Graphic Controls' CLARAVUE Pre-wired Electrode set does not meet required electrical specifications for defibrillation use. The device fails to withstand 5,000 volts without breakdown, potentially resulting in ineffective defibrillation.
Product
CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2022·2022-04-20
CLARAVUE Pre-wired Electrode fails to meet electrical safety specification
Graphic Controls' CLARAVUE Pre-wired Electrode units fail to meet electrical safety specifications required for defibrillation. The device delivers an inefficient electrical charge and may result in ineffective defibrillation.
Product
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1878-2019·2019-07-03
GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire se
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1876-2019·2019-07-03
GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk
GE Healthcare is recalling ECG leadwire sets because they may reduce energy reaching patients during defibrillation, potentially limiting treatment success.
Product
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1879-2019·2019-07-03
GE Healthcare Recalls Replacement ECG Leadwires Due to Defibrillation Risk
GE Healthcare is recalling 58,045 replacement ECG leadwires worldwide because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.
Product
Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets
Category
Medical Device
Distribution
Distributed nationwide