The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1756-2023·Announced 2023-06-28

Medtronic Implantable Cardioverter Defibrillators May Fail to Deliver Therapy

Medtronic issued a Class I recall for certain implantable cardioverter defibrillators due to a rare risk that high-voltage therapy may not deliver. Affected models include DTMA1QQ devices made with a specific 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 Class I medical device recall. While no deaths or serious injuries are yet reported, the potential for reduced or absent therapy output in life-saving defibrillation devices represents a serious patient safety risk, warranting classification as Severe.

Plain-English summary

Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), specifically the CRTD DTMA1QQ CLARIA MRI QUAD US DF4 model. The recall affects 58,706 units worldwide. These devices are manufactured with a specific glassed feedthrough component that poses a potential safety risk.

The FDA has classified this as a Class I recall because there is a rare potential for reduced or absent high-voltage therapy output (typically 0-12 joules) during defibrillation treatment. This means the device may not deliver the electrical shock needed to correct a dangerous heart rhythm, which is the device's primary function.

Patients with affected ICDs or CRT-Ds manufactured with the identified feedthrough are at risk. The devices have been distributed nationwide in the United States and worldwide. Specific lot numbers for affected units are available through Medtronic and the FDA.

Patients should contact their healthcare provider or Medtronic immediately to determine if their device is affected. Do not discontinue use of the device without medical guidance. Patients should discuss replacement or remediation options with their cardiologist. More information is available from the FDA's CDRH medical device recall database.

The recalled product

Product
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiovascular Defibrillator
Hazard
Affected units
58,706

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 CRTD DTMA1QQ CLARIA MRI QUAD US DF4
  • Lot Serial Numbers: RPA210493H
  • RPA222265H
  • RPA231080H
  • RPA238029H
  • RPA220160H
  • RPA224981H
  • RPA226922H
  • RPA226926H
  • RPA226931H
  • RPA226935H
  • RPA226936H
  • RPA231700H
  • RPA231701H
  • RPA231707H
  • RPA231708H
  • RPA231711H
  • RPA235632H
  • RPA235645H
  • RPA235649H

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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