Medtronic implantable defibrillators may fail to deliver therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators with specific feedthrough components may fail to deliver adequate high-voltage therapy output.
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: The FDA classified this as a Class I recall, which establishes a minimum severity rating of 4 per the rubric. Although no deaths or serious injuries have been reported, the potential for therapy failure in critical life-saving devices justifies this rating.
Plain-English summary
Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), Model DTMC2D1, manufactured with a specific feedthrough component may produce reduced or no energy output during high-voltage therapy delivery (typically 0-12J).
Approximately 10,197 units of these devices have been distributed to the United States and worldwide. The defect may be present in devices already implanted in patients and in currently available units.
The potential failure to deliver adequate high-voltage therapy output could prevent these devices from providing necessary treatment during critical cardiac events.
The recalled product
- Product
- CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; 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 00643169837652
- Lot Serial Numbers: RPR605458S
- RPR606698S
- RPR605664S
- RPR602262S
- RPR601954S
- RPR602352S
- RPR602691S
- RPR602236S
- RPR601128S
- RPR601184S
- RPR601760S
- RPR603209S
- RPR603275S
- RPR603699S
- RPR605742S
- RPR605761S
- RPR605767S
- RPR605779S
- RPR605784S
Distribution
Distributed nationwide across the United States.
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