Implantable Cardioverter Defibrillators May Fail During High Voltage Therapy
Medtronic implantable cardioverter defibrillators may fail to deliver therapy due to a defect in the electrical feedthrough. The devices risk reduced or no energy output during high-voltage treatment.
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 of an implantable cardiac device with potential for therapy delivery failure. Although no illnesses or deaths are reported, this defect directly threatens critical device function.
Plain-English summary
Medtronic has recalled 16,244 ICD-VR VISIA MRI AF S (Model DVFC3D4) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators due to a manufacturing defect in the electrical feedthrough component.
There is a rare potential for the devices to deliver reduced or no energy output during high-voltage (HV) therapy, typically in the range of 0 to 12 joules. This could prevent the device from effectively treating dangerous heart rhythms when therapy is needed.
The recalled devices were distributed nationwide in the United States and to facilities worldwide. Patients with affected implants should not remove their devices, as this may pose greater risk than the device remaining in place.
Patients should contact their cardiologist or cardiac device clinic immediately to verify whether their implant is part of this recall. Healthcare providers can check the device serial number against the recall lot numbers. Depending on findings, patients may require device monitoring or replacement.
The recalled product
- Product
- ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
- Affected units
- 16,244
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 00643169720817. Lot Serial Numbers: PMX613090S
- PMX610759S
- PMX613168S
- PMX604899S
- PMX606600S
- PMX605030S
- PMX605294S
- PMX605321S
- PMX605409S
- PMX605434S
- PMX605494S
- PMX605615S
- PMX605865S
- PMX605971S
- PMX606147S
- PMX606694S
- PMX606698S
- PMX606701S
- PMX606703S
- PMX606705S
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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