The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1719-2023·Announced 2023-06-28

Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk

Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The FDA has classified this as a Class I recall, which falls under the Critical category per the severity rubric. A malfunction in energy delivery for an implantable cardiac defibrillator represents a serious risk that could prevent life-saving therapy in dependent patients.

Plain-English summary

Medtronic Inc. is recalling the ICD-DR DDME3D1 MIRRO MRI implantable cardioverter defibrillators (ICDs) and certain cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. Approximately 2,831 units have been distributed nationwide and worldwide. These devices are identified by GTIN 00763000001568 and a large number of specific lot serial numbers (CWS600097S through CWS603267S).

There is a rare potential for reduced or no-energy output during high-voltage therapy, typically 0-12 joules. This defect could compromise the device's ability to deliver appropriate defibrillation therapy during cardiac arrhythmia events when such therapy is critical.

Patients with affected devices should contact their cardiologist or Medtronic immediately to determine whether their specific device is included in this recall. Healthcare providers should review implant records and patient identifiers to identify affected devices. Patients should not discontinue device use without medical guidance and should consult their healthcare provider for assessment and discussion of management or replacement options.

The recalled product

Product
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Category
Medical Device — Implantable cardiac defibrillator
Hazard
Affected units
2,831

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 00763000001568
  • Lot Serial Numbers: CWS603181S
  • CWS601328S
  • CWS601620S
  • CWS601980S
  • CWS602302S
  • CWS602482S
  • CWS602880S
  • CWS602742S
  • CWS602559S
  • CWS602607S
  • CWS602433S
  • CWS602957S
  • CWS601056S
  • CWS601348S
  • CWS601807S
  • CWS602219S
  • CWS602422S
  • CWS602474S
  • CWS601519S

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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