Medtronic Implantable Defibrillators May Fail to Deliver High-Voltage Therapy
Medtronic implantable defibrillators with a specific feedthrough defect may rarely experience reduced or no-energy output during high-voltage therapy. Patients should contact their healthcare provider for evaluation.
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 is classified as FDA Class I, which per the rubric requires a minimum severity score of 4 (Severe). Although no reported deaths or injuries are documented in the source text, the Class I designation indicates this is a serious hazard in a critical medical device that could prevent life-saving therapy delivery.
Plain-English summary
A rare potential for reduced or no-energy output during high-voltage (HV) therapy (typically 0-12 joules) has been identified in Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DVMB1D4, manufactured with a specific glassed feedthrough. The recall affects 20 units distributed in the United States and worldwide.
This defect in the feedthrough component could result in reduced or no-energy output when the device attempts to deliver high-voltage therapy. Since these devices are designed to automatically deliver therapy in response to dangerous cardiac rhythms, a failure to deliver adequate energy could prevent life-saving treatment.
Patients with affected devices should contact their healthcare provider or Medtronic to determine whether their device is involved in this recall. Further guidance regarding corrective measures should be obtained from healthcare providers and the manufacturer.
The recalled product
- Product
- ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- energy-output-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 00643169720558
- Lot Serial Numbers: PKZ212063H
- PKZ212047H
- PKZ212048H
- PKZ212049H
- PKZ212050H
- PKZ212055H
- PKZ212061H
- PKZ212062H
- PKZ212042H
- PKZ212039H
- PKZ212041H
- PKZ212027H
- PKZ212032H
- PKZ212033H
- PKZ212035H
- PKZ212044H
- PKZ212053H
- PKZ212054H
- PKZ212056H
Distribution
Distributed nationwide across the United States.
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