Medtronic Implantable Defibrillators Risk Failure to Deliver High-Voltage Therapy
Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a specific feedthrough may fail to deliver high-voltage therapy. The FDA is recalling 28,172 units as a Class I safety issue.
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 represents a direct threat to public health. Although no illnesses or injuries have been reported, the potential for reduced or no-energy output in a critical life-support device justifies this regulatory urgency and severity level.
Plain-English summary
Medtronic Inc. is recalling implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTMB2QQ, manufactured with a specific glassed feedthrough design. The recall affects 28,172 units distributed worldwide.
These devices carry a rare potential for reduced or no-energy output during high-voltage therapy (typically 0-12 joules). This malfunction could prevent the device from delivering therapy when needed, which is critical for patients depending on these devices for cardiac rhythm management.
If you have received one of the affected devices, contact your healthcare provider to determine if your device is subject to this recall. Do not discontinue use without medical guidance. Patients should discuss this recall with their healthcare provider for further guidance.
The recalled product
- Product
- CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- reduced-energy-output
- therapy-failure
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 00643169720695
- Lot Serial numbers: RPG619037S
- RPG608482S
- RPG611787S
- RPG619305S
- RPG609628S
- RPG622247S
- RPG619130S
- RPG623603S
- RPG610818S
- RPG616992S
- RPG619816S
- RPG624535S
- RPG614089S
- RPG619704S
- RPG619714S
- RPG623002S
- RPG624602S
- RPG607260S
- RPG607434S
Distribution
Distributed nationwide across the United States.
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