The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1762-2023·Announced 2023-06-28

Medtronic Cardiac Defibrillators Potentially Fail to Deliver High-Voltage Therapy

Medtronic's implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) may fail to deliver high-voltage therapy due to a defect in specific glassed feedthrough components. The FDA classified this as a Class I recall due to potential for serious harm.

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 FDA Class I recall of an implantable life-sustaining device meets the minimum score of 4, as the Class I designation reflects the FDA's determination of reasonable probability of serious adverse health consequences. No illnesses or injuries have been reported to date.

Plain-English summary

Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMB1D4 (AMPLIA MRI US DF4), due to a potential manufacturing defect. These devices may exhibit reduced or no-energy output during high-voltage therapy (typically 0-12 joules) due to a specific glassed feedthrough component. Approximately 2,767 units are affected worldwide and in the United States.

Failure to deliver adequate energy during high-voltage therapy could prevent the defibrillator from treating life-threatening cardiac arrhythmias. Without proper therapy delivery, affected devices would not be able to respond to dangerous heart rhythms requiring defibrillation. Although no illnesses or injuries have been reported, the FDA classified this as a Class I recall, reflecting the agency's determination that there is a reasonable probability the defect could result in serious harm.

This recall was issued by Medtronic Inc. in coordination with the U.S. Food and Drug Administration.

The recalled product

Product
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiac Device
Hazard
Affected units
2,767

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 00643169720718
  • Lot Serial Numbers: RPJ204877H
  • RPJ205009H
  • RPJ205996H
  • RPJ206294H
  • RPJ205851H
  • RPJ206501H
  • RPJ205969H
  • RPJ205051H
  • RPJ206429H
  • RPJ205893H
  • RPJ205344H
  • RPJ206237H
  • RPJ206208H
  • RPJ206032H
  • RPJ206082H
  • RPJ206104H
  • RPJ205080H
  • RPJ205234H
  • RPJ206059H

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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