Implantable Defibrillators May Fail to Deliver High-Voltage Therapy Energy
Certain Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during therapy due to a feedthrough defect. Approximately 11,794 units worldwide are affected.
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 medical device recall. The rule states FDA Class I recalls never score below 4. The device may fail to deliver critical high-voltage therapy, compromising treatment effectiveness. No illnesses or injuries have been reported.
Plain-English summary
The FDA is recalling certain Medtronic CRTD DTMA1D1 CLARIA MRI implantable cardioverter defibrillators and related ICDs due to a potential defect in the high-voltage feedthrough. These devices may produce reduced or no energy output during high-voltage therapy delivery, typically in the 0-12 joule range, which could prevent proper treatment in patients dependent on the device.
The defect affects implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators manufactured with a specific glassed feedthrough component. Approximately 11,794 units are affected, with distribution across the United States and worldwide.
Patients with affected devices should contact their healthcare provider or Medtronic to determine if their specific device is included in this recall. Healthcare providers should review patient records to identify affected devices and discuss appropriate management options with each patient.
The recalled product
- Product
- CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
- Affected units
- 11,794
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 00643169837676
- Lot Serial Numbers: RPT208454H
- RPT211000H
- RPT208258H
- RPT211071H
- RPT211077H
- RPT210886H
- RPT209224H
- RPT211338H
- RPT211343H
- RPT211344H
- RPT211347H
- RPT208864H
- RPT210392H
- RPT204063H
- RPT207540H
- RPT210779H
- RPT211477H
- RPT210662H
- RPT203810H
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
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