The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1780-2023·Announced 2023-06-28

Medtronic ICD COBALT XT implants may deliver reduced or no therapy

Medtronic's ICD COBALT XT HF QUAD implantable defibrillators may deliver reduced or no energy output during high voltage therapy. The FDA has classified this as a Class I recall.

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 is an FDA Class I recall, which establishes a minimum severity of 4 per the rubric. Although the hazard is described as a 'rare potential' and no illnesses have been reported, FDA Class I classification indicates a reasonable probability of serious harm. The inability to deliver electrical therapy from an implanted defibrillator poses direct risk to patient safety.

Plain-English summary

Medtronic Inc. is recalling ICD COBALT XT HF QUAD OUS implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), devices used to deliver electrical therapy for dangerous heart rhythms. The recall affects 9 units manufactured with a specific feedthrough component.

There is a rare potential for these devices to deliver reduced or no energy output during high voltage therapy (typically 0–12 joules). This malfunction could prevent the device from properly terminating dangerous arrhythmias when therapy is needed.

Affected devices were distributed nationwide and worldwide. Patients with the following serial numbers may have devices at risk: RTC614024S, RTC617998S, RTC614026S, RTC617999S, RTC618002S, RTC618007S, RTC621332S, RTC614023S, and RTC611661S. The FDA has classified this as a Class I recall.

Patients should contact their healthcare provider or Medtronic immediately to determine if their device is affected and discuss next steps.

The recalled product

Product
ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiac Implants
Hazard
Affected units
9

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 (10)

  • GTIN 00763000501020
  • Lot Serial Numbers: RTC614024S
  • RTC617998S
  • RTC614026S
  • RTC617999S
  • RTC618002S
  • RTC618007S
  • RTC621332S
  • RTC614023S
  • RTC611661S

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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