Implantable Defibrillators May Fail to Deliver Critical Therapy
Medtronic implantable defibrillators may produce reduced or no energy output during high-voltage therapy delivery. Affected devices were manufactured with a specific feedthrough component.
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: FDA Class I classification mandates a minimum score of 4 per the rubric. While no deaths or injuries are explicitly reported in this notice, the potential failure of critical high-voltage defibrillation therapy in ICDs and CRT-Ds represents a serious health risk warranting the most urgent regulatory action.
Plain-English summary
Medtronic Inc. is recalling certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMC2QQ COMPIA MRI QUAD OUS DF4. The devices were manufactured with a specific feedthrough component and have been distributed nationwide in the United States and internationally.
The affected devices present a rare potential for reduced or no-energy output during high-voltage (HV) therapy delivery, typically at dose levels of 0-12 joules. High-voltage therapy provides the defibrillation function necessary to treat dangerous cardiac arrhythmias. Inadequate or absent energy output could prevent the device from delivering this critical therapy.
Approximately 31,884 units are affected by this FDA Class I recall. The FDA's Class I classification indicates the most serious category of recall due to potential for serious adverse health consequences. Affected devices are identified through specific lot serial numbers.
Patients with implanted devices should identify their device serial number and verify whether it appears on the recall list provided by Medtronic. Healthcare providers should check affected serial numbers for their patients and follow Medtronic's guidance for appropriate device management.
The recalled product
- Product
- CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators
- Affected units
- 31,884
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 00643169720688
- Lot Serial numbers: RPF622750S
- RPF618290S
- RPF616459S
- RPF619209S
- RPF620414S
- RPF613519S
- RPF617908S
- RPF607263S
- RPF605123S
- RPF606355S
- RPF607965S
- RPF607966S
- RPF607968S
- RPF607969S
- RPF610837S
- RPF612639S
- RPF613175S
- RPF613176S
- RPF614678S
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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