Implantable Cardioverter Defibrillators May Fail to Deliver Therapy
Medtronic is recalling 15,381 implantable cardioverter defibrillators due to rare potential for reduced or absent energy output during high-voltage therapy caused by a specific feedthrough design defect.
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 classification mandates a minimum severity score of 4. Although no illnesses or injuries have been reported and the failure mechanism is currently theoretical, the potential for implantable defibrillators to fail therapy delivery during life-threatening cardiac events represents a serious hazard.
Plain-English summary
Medtronic Inc. is recalling 15,381 units of the ICD-VR VISIA MRI AF XT OUS DF4 implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D), Model Number DVFB2D4. The devices may produce reduced or completely absent energy output during high-voltage (HV) therapy, typically in the 0-12J range, due to a defect in a specific feedthrough component.
If a dangerous heart rhythm is detected, the device may fail to deliver the necessary defibrillation energy. This rare but potentially serious defect could prevent life-saving therapy in patients who depend on their device to treat life-threatening arrhythmias.
The affected devices have been distributed nationwide in the United States and worldwide. Patients who have received one of these devices should contact their cardiologist or physician to determine whether they have an affected unit and discuss next steps.
The recalled product
- Product
- ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
- Affected units
- 15,381
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 00643169717992
- Lot Serial Numbers: PLX607314S
- PLX608121S
- PLX612778S
- PLX613087S
- PLX604547S
- PLX610926S
- PLX606361S
- PLX608125S
- PLX610724S
- PLX610983S
- PLX609285S
- PLX608127S
- PLX608938S
- PLX610866S
- PLX612123S
- PLX608086S
- PLX608118S
- PLX609410S
- PLX610864S
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
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