Implantable Cardioverter Defibrillators May Fail To Deliver Therapy; Class I Recall
Medtronic implantable cardioverter defibrillators (ICDs) may fail to deliver high-voltage therapy due to a manufacturing defect in a specific feedthrough component. 447 units are affected worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall involves an FDA Class I medical device with a potential therapy failure defect. FDA Class I recalls must score at least 4 per the rubric; the score remains 4 (not 5) because no serious injuries or deaths have been reported and the hazard is described as rare and potential.
Plain-English summary
Medtronic Inc. is recalling the ICD-VR DVBB2D4 EVERA XT DF4 INTL implantable cardioverter defibrillator due to a potential defect in the device's feedthrough component. The feedthrough is the internal part that connects the device's leads to the implantable unit. Devices manufactured with a specific type of feedthrough may rarely produce reduced or no energy output during high-voltage therapy (typically 0-12 joules).
The recall affects 447 units distributed throughout the United States and worldwide. Specific lot serial numbers have been identified by the manufacturer and are available from Medtronic and the FDA.
The recalled product
- Product
- ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- reduced-energy-output
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 00643169218024
- Lot Serial Numbers: BWJ607141S
- BWJ607132S
- BWJ607040S
- BWJ607055S
- BWJ607056S
- BWJ607025S
- GTIN 00643169969575
- Lot Serial Numbers: BWJ607007S
- BWJ607008S
- BWJ607010S
- BWJ607011S
- BWJ607012S
- BWJ607015S
- BWJ607020S
- BWJ607022S
- BWJ607024S
- BWJ607029S
- BWJ607034S
- BWJ607035S
Distribution
Distributed nationwide across the United States.
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