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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class I recall. Per the severity rubric, FDA Class I recalls receive a minimum score of 4 (Severe), even when injuries have not been reported. The potential for reduced or absent energy output in an implantable defibrillator could prevent life-saving therapy delivery during cardiac emergencies.
Plain-English summary
Medtronic Inc. is recalling approximately 25,058 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model Number DVMC3D4 (ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB). These devices were distributed nationwide and worldwide.
The devices contain a specific feedthrough component that may have a defect. There is a rare potential for reduced or no-energy output during high-voltage (HV) therapy, typically at 0-12 joules. This malfunction could prevent the device from delivering necessary therapy during life-threatening cardiac arrhythmias.
Patients with one of these devices should contact their healthcare provider for guidance. The manufacturer has identified specific lot serial numbers associated with the defect. Healthcare providers can determine if an individual device is affected and recommend appropriate follow-up actions.
The recalled product
- Product
- ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
- Affected units
- 25,058
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00643169720596
- Lot Serial Numbers: PMZ618802S
- PMZ616324S
- PMZ616325S
- PMZ618783S
- PMZ614007S
- PMZ616319S
- PMZ616311S
- PMZ616317S
- PMZ616329S
- PMZ614015S
- PMZ614036S
- PMZ616320S
- PMZ613982S
- PMZ615518S
- PMZ616318S
- PMZ616327S
- PMZ618780S
- PMZ618807S
- PMZ618813S
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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Same hazard · energy output failure
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators risk energy output failure during high voltage therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Recalled for Rare Risk of Energy Output Failure
FDA (Devices) · 2023-06-28
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