The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1704-2023·Announced 2023-06-28

Implantable defibrillators may fail to deliver high-voltage therapy due to defect

Medtronic's EVERA XT implantable defibrillators may fail to deliver high-voltage therapy in certain models manufactured with a defective feedthrough. Patients should consult their cardiologist.

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 a FDA Class I recall of implantable cardiac devices with potential for complete therapy failure. While no deaths, serious injuries, or hospitalizations are reported in the source, the hazard is critical for a life-saving device. Class I classification mandates a minimum severity level of Severe, with Critical reserved for recalls with reported deaths or serious injuries.

Plain-English summary

Medtronic Inc. has recalled 2,179 units of the EVERA XT IS1/DF1 defibrillators (ICDs and CRT-Ds) distributed nationwide and worldwide. The recall concerns a rare potential for reduced or complete loss of energy output during high-voltage therapy, typically at 0-12J, in devices manufactured with a specific glassed feedthrough.

Affected devices are identified by GTIN 00643169720404 and GTIN 00763000059569 with specific lot numbers beginning with BWC. The defect affects both standard implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Patients who have received one of these devices should contact their cardiologist or healthcare provider to determine if their device is affected and discuss appropriate monitoring or replacement options. The FDA classified this as a Class I recall.

The recalled product

Product
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable cardiac device
Hazard
Affected units
2,179

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 00643169720404
  • Lot Serial Numbers: BWC242988H
  • BWC241999H
  • BWC242338H
  • BWC242392H
  • BWC243112H
  • BWC243417H
  • BWC243633H
  • BWC243786H
  • BWC244004H
  • BWC241880H
  • BWC242816H
  • BWC243834H
  • BWC241861H
  • BWC242999H
  • BWC241742H
  • BWC241891H
  • BWC241930H
  • BWC242022H
  • BWC242027H

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 →

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