Medtronic Implantable Heart Defibrillators Risk Therapy Delivery Failure
Medtronic CRT-D and ICD implantable defibrillators may fail to deliver therapy due to a rare defect in a specific feedthrough component. The recalled devices carry a potential for reduced or no-energy output during high-voltage heart rhythm treatment.
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 classification applies because this device malfunction could result in serious injury or death. The potential for reduced or no-energy output during critical high-voltage therapy poses a direct life-threatening risk to patients with implanted cardiac devices requiring defibrillation.
Plain-English summary
Medtronic has recalled certain CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL implantable cardioverter defibrillators and ICDs manufactured with a specific glassed feedthrough component. These are implantable medical devices designed to deliver electrical therapy to restore normal heart rhythm.
The recalled devices carry a rare potential for reduced or no-energy output during high-voltage therapy, typically delivering 0-12 joules of energy. The defect is located in the feedthrough component, a critical electrical pathway within the device that conducts current necessary for therapy delivery.
Approximately 2,904 units have been distributed nationwide and worldwide. Patients with any of the affected lot serial numbers should contact their healthcare provider or Medtronic immediately.
Patients with affected devices should consult their healthcare provider to discuss evaluation, monitoring, and possible device replacement. Device failure to deliver therapy during a life-threatening arrhythmia could result in serious harm.
The recalled product
- Product
- CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-delivery-failure
- feedthrough-defect
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 00643169217966
- Lot Serial Numbers: BLI613233S
- BLI613324S
- BLI613699S
- BLI614038S
- BLI614165S
- BLI613293S
- BLI613712S
- BLI613772S
- BLI614301S
- BLI613871S
- BLI614140S
- BLI614826S
- BLI612567S
- BLI614031S
- BLI613259S
- BLI613417S
- BLI614737S
- BLI614194S
- BLI614210S
Distribution
Distributed nationwide across the United States.
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