Implantable Defibrillators May Fail to Deliver Therapy in Rare Cases
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may rarely fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough.
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 FDA Class I, which mandates a minimum severity score of 4. The device malfunction represents a potential threat to life due to the device's critical cardiac function, despite no documented reported deaths or injuries in the source material.
Plain-English summary
Medtronic Inc. is recalling 10,370 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) model DTMB1QQ AMPLIA MRI QUAD US DF4. The devices contain a rare potential defect affecting a specific feedthrough component.
Affected devices may produce reduced or no energy output during high-voltage therapy, typically delivered at 0-12 joules. This malfunction could prevent the device from delivering needed therapy to correct dangerous heart rhythms.
The recall affects devices distributed nationwide and worldwide. Specific lot serial numbers are identified in the FDA recall database.
Patients who have received these devices should contact Medtronic or their healthcare provider for information about whether their device is affected and what steps they should take.
The recalled product
- Product
- CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- reduced-energy-output
- cardiac-device-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 00643169720671
- Lot Serial Numbers: RPE221706H
- RPE221707H
- RPE221708H
- RPE221712H
- RPE221714H
- RPE221715H
- RPE222453H
- RPE222479H
- RPE222484H
- RPE222493H
- RPE223082H
- RPE223083H
- RPE223085H
- RPE223086H
- RPE223087H
- RPE224112H
- RPE224115H
- RPE224116H
- RPE224117H
Distribution
Distributed nationwide across the United States.
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