The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1821-2023·Announced 2023-06-28

Implantable cardiac defibrillators recalled for potential therapy failure risk

Medtronic recalls ICD COBALT VR MRI DF4 defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect affects devices manufactured with a specific glassed feedthrough component.

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 classified this recall as Class I, which mandates a minimum severity of Severe per the rubric. Although no illnesses or injuries have been reported, the potential for reduced or no energy output in a life-critical cardiac device constitutes a serious malfunction risk that could prevent lifesaving therapy.

Plain-English summary

The ICD COBALT VR MRI DF4 implantable cardioverter defibrillators are being recalled due to a rare potential for reduced or no energy output during high-voltage therapy delivery. The defect is associated with a specific type of glassed feedthrough component used in the device.

High-voltage therapy is typically delivered at 0-12 joules. In affected devices, this therapy may not reach target energy levels or may fail to deliver entirely, potentially preventing the device from functioning as intended when therapy is needed.

This recall affects 7,048 units distributed nationally and worldwide. Medtronic and the FDA have identified the specific lot serial numbers associated with this issue.

Patients with affected devices should contact their healthcare provider or Medtronic immediately to determine if their device is part of this recall and discuss any necessary next steps, including potential device monitoring or replacement.

The recalled product

Product
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiac / Implantable Defibrillator
Hazard
Affected units
7,048

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 00763000178512
  • Lot Serial Numbers: RSF600012S
  • RSF600254S
  • RSF600591S
  • RSF600655S
  • RSF600822S
  • RSF601247S
  • RSF602653S
  • RSF603908S
  • RSF601102S
  • RSF607914S
  • RSF605967S
  • RSF600633S
  • RSF600649S
  • RSF600867S
  • RSF600868S
  • RSF600869S
  • RSF600872S
  • RSF600873S
  • RSF600874S

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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Same hazard · reduced energy output

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