Implantable Cardiac Defibrillators May Deliver Reduced Energy Output
Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class I classification indicates potential for serious harm. However, no illnesses or injuries have been reported, and the hazard is described as a rare potential rather than a confirmed occurrence. This fits the rubric's category of 'risk-of-harm products where injury has not yet been reported,' placing it at the High severity level.
Plain-English summary
Medtronic Inc. is recalling certain CRTD DTMA1D4 CLARIA MRI US DF4 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators (approximately 12,291 units). These devices may deliver reduced or no energy output during high voltage therapy due to a defect in a specific type of feedthrough component.
High voltage therapy, typically delivered at 0-12 joules, is critical for treating life-threatening heart rhythms. When a device is manufactured with the specific glassed feedthrough at issue, there is a rare potential that the device will not deliver adequate energy during therapy.
The affected devices were distributed nationwide and internationally. No deaths, injuries, or illnesses related to this issue have been reported to the FDA as of this recall.
The recalled product
- Product
- CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Hazard
- device-malfunction
- 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 00643169720657
- Lot Serial Numbers: RPC203306H
- RPC205335H
- RPC207546H
- RPC210227H
- RPC205865H
- RPC205916H
- RPC205937H
- RPC206296H
- RPC206416H
- RPC206665H
- RPC207309H
- RPC207864H
- RPC208393H
- RPC209253H
- RPC209691H
- RPC209707H
- RPC209745H
- RPC209762H
- RPC209847H
Distribution
Distributed nationwide across the United States.
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