Implantable Cardiac Defibrillators May Fail During High-Voltage Therapy
Certain Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy due to a defective feedthrough component. Affected devices were distributed nationwide and worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity rating of 4. Although no illnesses or injuries have been reported and the hazard is described as rare, the potential for reduced or complete failure of high-voltage therapy in implantable cardiac defibrillators—devices critical for preventing sudden cardiac death—justifies this severe rating.
Plain-English summary
The recall affects implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific type of glassed feedthrough component. The defect creates a rare potential for reduced or no-energy output during high-voltage therapy, typically at dose levels of 0-12 joules.
The affected devices include the CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1 model. A total of 1,658 units have been identified as potentially affected. These devices are distributed in the United States and worldwide.
The defective feedthrough component may cause therapy failure when the device needs to deliver high-voltage treatment. Patients with affected devices should contact their healthcare provider or Medtronic immediately. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- device-malfunction
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 00643169837614
- Lot Serial numbers: RPN602297S
- RPN602079S
- RPN601385S
- RPN601320S
- RPN601216S
- RPN601977S
- RPN602107S
- RPN600885S
- RPN601199S
- RPN600682S
- RPN601504S
- RPN601513S
- RPN601653S
- RPN601681S
- RPN602258S
- RPN600961S
- RPN600858S
- RPN600867S
- RPN600868S
Distribution
Distributed nationwide across the United States.
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