Implantable Defibrillators May Fail to Deliver Therapy Due to Feedthrough Defect
Medtronic's ICD-VR DVMB2D4 implantable defibrillators may fail to deliver electrical therapy due to a defect in the feedthrough component. The recall affects 6,477 units distributed 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: This is an FDA Class I recall of an implantable cardiac device with potential for therapeutic failure. Although the risk is rare and no deaths or serious injuries have been reported, the hazard involves a life-critical device that may fail to deliver necessary therapy, meeting the FDA Class I threshold of Severe (score 4).
Plain-English summary
Medtronic Inc. is recalling the ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL implantable cardioverter defibrillator (ICD) due to a potential defect in its electrical feedthrough component. A total of 6,477 units have been distributed in the United States and worldwide.
The affected devices may experience reduced or no energy output during high voltage therapy delivery (typically 0-12 joules). This defect is caused by a specific type of feedthrough used in manufacturing these devices. Although the risk is described as rare, failure could prevent the device from delivering necessary therapy.
Patients with affected devices should contact their healthcare provider or Medtronic to determine if their specific device is included in this recall and to discuss next steps, which may include device replacement or closer monitoring.
The recalled product
- Product
- ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
- Affected units
- 6,477
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 00643169720565
- Lot Serial Numbers: PLZ611718S
- PLZ611713S
- PLZ611719S
- PLZ613233S
- PLZ613240S
- PLZ613268S
- PLZ613269S
- PLZ613270S
- PLZ610634S
- PLZ612616S
- PLZ613234S
- PLZ610657S
- PLZ611892S
- PLZ610319S
- PLZ610320S
- PLZ610622S
- PLZ610625S
- PLZ610626S
- PLZ610627S
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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