The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1778-2023·Announced 2023-06-28

Implantable Defibrillators May Deliver Reduced Energy During Therapy

Medtronic ICDs and CRT-Ds with a specific feedthrough may deliver reduced or no energy during high voltage therapy. Approximately 2,669 units are affected 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: This is a Class I FDA recall, which establishes a minimum severity level of 4 per the rubric rule that FDA Class I classifications never go below 4. No reported illnesses or injuries are mentioned in the source material, and the hazard is described as a rare potential, preventing elevation to Critical (which requires reported deaths or serious injuries).

Plain-English summary

Medtronic's CRTD COBALT XT HF QUAD MRI IS4 DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are subject to this Class I FDA recall. The devices are manufactured with a specific type of feedthrough that presents a rare potential for reduced or complete loss of energy output during high voltage therapy, typically between 0 and 12 joules.

Approximately 2,669 units are affected by this recall and have been distributed in the United States and worldwide. The issue affects devices from multiple lot/serial numbers spanning three product codes. Patients implanted with these affected devices may not receive appropriate therapy during arrhythmia treatment.

Patients who believe they may have one of the affected devices should contact Medtronic and consult with their implanting cardiologist or electrophysiologist. Healthcare providers can verify whether a device matches the recalled lots using the specific lot/serial numbers provided in the FDA recall notice.

The recalled product

Product
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable Cardiovascular Device
Hazard
Affected units
2,669

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 00763000178109
  • Lot Serial numbers: RTD602437S
  • RTD602300S
  • RTD602301S
  • RTD602414S
  • RTD602417S
  • RTD602418S
  • RTD602419S
  • RTD601286S
  • RTD600407S
  • RTD600686S
  • RTD600687S
  • RTD600688S
  • RTD600689S
  • RTD601807S
  • RTD602096S
  • RTD602321S
  • RTD601977S
  • RTD600375S
  • RTD600427S

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 →

Related recalls

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

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Same hazard · reduced energy output

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