Medtronic implantable defibrillators recalled for potential therapy delivery failure
Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.
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: FDA Class I recall classification requires minimum score of 4. While no illnesses or injuries are currently reported, the potential failure mode—reduced or absent energy output in a life-critical cardiac device—represents serious risk of harm affecting approximately 5,296 implanted devices.
Plain-English summary
Medtronic is recalling specific models of ICD-VR DVBC3D4 EVERA S DF4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that may experience reduced or no-energy output during high voltage therapy.
The recalled devices contain a specific feedthrough component that could potentially fail to deliver the full therapeutic energy during high-voltage therapy (typically 0-12 joules). This is a Class I recall, the FDA's most serious classification.
Approximately 5,296 units have been distributed nationwide and worldwide. Patients who have received one of these devices should contact their healthcare provider immediately to discuss monitoring and any necessary action. Healthcare providers should review the FDA recall notice for specific lot numbers and model information.
The recalled product
- Product
- ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
- Affected units
- 5,296
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 00643169720442
- Lot Serial Numbers: BWL206052H
- BWL205879H
- BWL206062H
- BWL206106H
- BWL206057H
- BWL206066H
- BWL206087H
- BWL205882H
- BWL206049H
- BWL206050H
- BWL206053H
- BWL206055H
- BWL206059H
- BWL206069H
- BWL206073H
- BWL206074H
- BWL206078H
- BWL206079H
- BWL206081H
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
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · reduced energy output
See all →- SevereImplantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators may deliver reduced or no energy during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable cardioverter defibrillators may output reduced or no energy during therapy
FDA (Devices) · 2023-06-28
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