The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1803-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure

Medtronic implantable cardioverter defibrillators (ICDs) with a specific feedthrough component may have reduced or absent energy output during high voltage therapy. The FDA Class I recall affects 12,099 units distributed nationwide and worldwide.

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 of implantable cardioverter defibrillators, a life-critical medical device. Per the rubric, FDA Class I recalls cannot be scored below 4, regardless of reported illnesses or injuries. The hazard—potential failure of high voltage therapy output—represents a functional defect in a device essential for cardiac rhythm management.

Plain-English summary

Medtronic Inc. has recalled the ICD-VR DVFB1D1 VISIA AF MRI US DF1 implantable cardioverter defibrillator (ICD). The recall affects 12,099 units distributed nationwide and worldwide.

The recall addresses a rare potential for reduced or absent energy output during high voltage (HV) therapy, typically at 0-12 joules. This defect affects implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component.

Patients with implanted devices from the affected lot numbers are identified by specific serial numbers listed in the recall documentation. The affected lot numbers can be verified through implant records or by contacting Medtronic.

Patients should consult their healthcare provider or cardiologist regarding their specific device. The FDA and Medtronic recommend that physicians assess whether their patients with affected devices require any clinical intervention.

The recalled product

Product
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Device
Hazard
Affected units
12,099

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 00643169837799
  • Lot Serial Numbers: CWG208686H
  • CWG211264H
  • CWG205930H
  • CWG208117H
  • CWG210956H
  • CWG210958H
  • CWG211814H
  • CWG212178H
  • CWG208135H
  • CWG209489H
  • CWG209599H
  • CWG212702H
  • CWG214349H
  • CWG214379H
  • CWG206584H
  • CWG208347H
  • CWG206776H
  • CWG206895H
  • CWG211478H

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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