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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 10,197
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.
Part of a larger recall action
This product is one of 120 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 120 products in this recall →Related recalls
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