The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1737-2023·Announced 2023-06-28

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.

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: 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)
Category
Medical Device — Implantable Cardiac Devices
Hazard
Affected units
2,904

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.

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

Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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