The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1714-2023·Announced 2023-06-28

Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output

Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.

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 designation reflects the agency's determination that there is a reasonable probability of serious adverse health consequences or death. Although the hazard is rare and no adverse events have been reported, the Class I classification requires a minimum severity score of 4 per the rubric.

Plain-English summary

Medtronic is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that were manufactured with a specific glassed feedthrough. The affected model is the ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT. Approximately 35,961 units have been distributed in the United States and worldwide.

There is a rare potential for reduced or no energy output during high voltage therapy (typically 0-12 joules) in these devices. This hazard could prevent the device from delivering the electrical therapy necessary to treat life-threatening heart arrhythmias. The FDA classified this recall as Class I, indicating a serious risk to health and safety.

Patients with these implanted devices should confirm their device model and serial number and contact their healthcare provider or Medtronic for specific information about their device and whether additional evaluation is needed.

The recalled product

Product
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Cardiovascular
Hazard
Affected units
35,961

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 00643169443419
  • Lot Serial Numbers: PGZ624363S
  • PGZ631078S
  • PGZ638449S
  • PGZ638465S
  • PGZ623851S
  • PGZ645877S
  • PGZ621671S
  • PGZ621673S
  • PGZ623094S
  • PGZ623561S
  • PGZ623984S
  • PGZ623985S
  • PGZ623986S
  • PGZ623991S
  • PGZ624447S
  • PGZ626933S
  • PGZ626995S
  • PGZ627005S
  • PGZ627071S

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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