Agency classClass IOur severity:Severe FDA (Devices)·Z-1823-2023·Announced 2023-06-28

ICD defibrillators risk reduced or absent therapy output from feedthrough defect

Certain ICD defibrillators may produce reduced or no energy output during high-voltage therapy due to a feedthrough defect. FDA Class I recall affects approximately 2,031 units 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: FDA Class I classification mandates a minimum severity score of 4. Although no illnesses or deaths are reported, the potential for therapy failure in a life-critical implanted cardiac device represents a serious safety risk.

Plain-English summary

The FDA has issued a Class I recall of ICD CROME VR MRI DF4 implantable cardioverter defibrillators (Model Number DVPC3D4) manufactured by Medtronic Inc. These devices contain a feedthrough component that may result in reduced or no energy output during high-voltage therapy (typically 0-12 joules). Approximately 2,031 units are affected, with distribution in the United States and worldwide.

The potential for reduced or absent energy output during cardiac defibrillation therapy is a serious safety concern. These devices are implanted to treat life-threatening heart rhythm disturbances, and failure to deliver adequate defibrillation energy when needed could prevent appropriate treatment of dangerous cardiac events.

Patients implanted with an ICD CROME VR MRI DF4 should verify with their healthcare provider whether their device is subject to this recall based on the product lot serial number.

The recalled product

Product: ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category: Medical Device — Implantable Cardioverter Defibrillator
Hazard: device-malfunction
therapy-failure
energy-output-defect
Affected units: 2,031

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 00763000178550. Lot Serial Numbers: RSH600068S
RSH600173S
RSH600239S
RSH601126S
RSH601127S
RSH601883S
RSH601888S
RSH601444S
RSH601463S
RSH601537S
RSH601538S
RSH600064S
RSH600099S
RSH600174S
RSH600175S
RSH600228S
RSH600275S
RSH600276S
RSH600889S
RSH600903S

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 →

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

See all →

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Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
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Medtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
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Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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Same hazard · device malfunction