The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1717-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Risk Reduced or No Therapy Output

Certain Medtronic implantable cardioverter defibrillators and cardiac resynchronization defibrillators may fail to deliver energy during high-voltage therapy due to a specific feedthrough design issue. The recall affects 3,801 units distributed in the US 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 requires a minimum severity score of 4. Although no illnesses or injuries have been reported and the hazard is theoretical (described as rare potential), the critical function at risk—high-voltage defibrillation therapy—justifies the FDA's highest recall classification.

Plain-English summary

Certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough may deliver reduced or no energy output during high-voltage therapy. The devices affected include the ICD-DR DDMD3D1 PRIMO MRI model and other similar units using this feedthrough design.

The recall involves 3,801 units distributed in the United States and worldwide. High-voltage therapy typically operates in the 0-12 joule range. While the potential for this malfunction is described as rare, it could prevent essential defibrillation therapy when needed.

Patients and healthcare providers should contact Medtronic or their device clinic for evaluation and guidance regarding their specific device. The FDA classified this as a Class I recall due to the critical life-saving function at risk.

No injuries or illnesses have been reported in connection with this issue to date. However, the potential for therapy failure in a critical cardiac event justified the Class I recall designation.

The recalled product

Product
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiac Device
Hazard
Affected units
3,801

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 00763000001483
  • Lot Serial Numbers: CWM603134S
  • CWM600439S
  • CWM601269S
  • CWM603840S
  • CWM603922S
  • CWM601037S
  • CWM602990S
  • CWM603292S
  • CWM602888S
  • CWM602567S
  • CWM604350S
  • CWM604400S
  • CWM604147S
  • CWM604447S
  • CWM603919S
  • CWM604293S
  • CWM603993S
  • CWM604453S
  • CWM604276S

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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