The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1795-2023·Announced 2023-06-28

Implantable Defibrillators May Deliver Reduced or No Energy During Therapy

Certain Medtronic implantable cardioverter defibrillators with a specific feedthrough may produce reduced or no energy output during high voltage therapy. The rare defect affects 16 units distributed nationwide.

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: This is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. No deaths, injuries, or illnesses are reported in the source text, preventing a Critical rating.

Plain-English summary

This recall involves Medtronic Inc.'s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Model DVBB1D1 (EVERA XT IS1/DF1 US). The devices are being recalled due to a rare potential for reduced or no energy output during high voltage therapy.

The defect is caused by a specific (glassed) feedthrough used in the device. During high voltage therapy (typically 0-12J), this feedthrough may rarely cause the device to produce reduced energy or no energy at all, potentially preventing the device from delivering therapy as intended.

The recall affects 16 units that were distributed nationwide and worldwide. The affected devices carry the following lot serial numbers: BWI218211H, BWI218218H, BWI218226H, BWI218228H, BWI218206H, BWI218224H, BWI218210H, BWI218222H, BWI218217H, BWI218214H, BWI218216H, BWI218208H, BWI218207H, BWI218221H, BWI218212H, and BWI218220H.

Patients implanted with these devices should contact their healthcare provider or Medtronic to verify whether their device is affected. Healthcare providers should review this recall notice and the FDA recall database for additional information and guidance.

The recalled product

Product
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardioverter Defibrillator
Hazard
Affected units
16

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 (17)

  • GTIN 00643169720466
  • Lot Serial Numbers: BWI218211H
  • BWI218218H
  • BWI218226H
  • BWI218228H
  • BWI218206H
  • BWI218224H
  • BWI218210H
  • BWI218222H
  • BWI218217H
  • BWI218214H
  • BWI218216H
  • BWI218208H
  • BWI218207H
  • BWI218221H
  • BWI218212H
  • BWI218220H

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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