Implantable Cardioverter Defibrillators May Fail to Deliver High Voltage Therapy
Medtronic implantable cardioverter defibrillators may produce reduced or no energy output during high voltage therapy due to a specific feedthrough manufacturing defect. Approximately 8,219 units were affected 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: This is an FDA Class I recall of a critical cardiac device. Per the severity rubric, FDA Class I recalls must never be scored below 4. Although the source describes the defect as a "rare potential" with no reported illnesses or injuries, the device's critical function in treating life-threatening heart rhythms and the potential for complete therapy failure justify the agency's Class I classification.
Plain-English summary
Medtronic has issued a Class I recall for specific implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DDME3D4. These devices are implanted in patients with serious heart rhythm disorders to detect and treat life-threatening arrhythmias.
The recall addresses a rare potential defect in devices manufactured with a specific glassed feedthrough component. Affected devices may produce reduced or no energy output during high voltage therapy (typically 0-12J). Because these devices are essential for treating potentially fatal heart rhythms, any failure to deliver therapy poses a serious health risk.
Approximately 8,219 units were distributed to patients nationwide and worldwide. Medtronic has identified specific lot serial numbers associated with the defect.
The recalled product
- Product
- ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- therapy-failure
- reduced-energy-output
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 00763000001582
- Lot Serial Numbers: CWT605432S
- CWT600264S
- CWT607420S
- CWT607213S
- CWT607463S
- CWT607388S
- CWT607425S
- CWT607374S
- CWT607359S
- CWT601622S
- CWT603529S
- CWT605876S
- CWT605723S
- CWT604657S
- CWT604666S
- CWT605105S
- CWT605034S
- CWT608381S
- CWT608194S
Distribution
Distributed nationwide across the United States.
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