Implantable Cardioverter Defibrillators Risk Failure to Deliver Therapy
Medtronic implantable cardioverter defibrillators with a specific feedthrough defect may rarely fail to deliver high-voltage therapy. Approximately 34,350 devices distributed worldwide are affected.
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: FDA Class I recalls of implantable cardiac devices are classified as Severe per the regulatory rubric. While no deaths or reported serious injuries are documented in the source, the potential for complete loss of critical life-saving therapy during a dangerous arrhythmia justifies this classification.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DVFB1D4, manufactured with a specific glassed feedthrough. Approximately 34,350 units are affected.
The devices carry a rare potential for reduced or no energy output during high-voltage therapy, typically in the 0-12 joule range. This defect could prevent the device from delivering necessary therapy when treating dangerous heart rhythms.
Affected devices have been distributed in the United States and worldwide. The FDA has classified this as a Class I recall, indicating the agency considers it a serious safety hazard. Patients implanted with affected devices should consult their healthcare provider for guidance.
The recalled product
- Product
- ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-delivery-failure
- device-malfunction
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 00643169720794
- Lot Serial Numbers: PKX219646H
- PKX220040H
- PKX220056H
- PKX221681H
- PKX222407H
- PKX222934H
- PKX223422H
- PKX225541H
- PKX228394H
- PKX228784H
- PKX228814H
- PKX230405H
- PKX231486H
- PKX232877H
- PKX233043H
- PKX236253H
- PKX238847H
- PKX238969H
- PKX224741H
Distribution
Distributed nationwide across the United States.
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