Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure
Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.
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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with…"
Plain-English summary
Medtronic Inc. is recalling 2,173 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), model DTMB1Q1, manufactured with a specific feedthrough component.
The affected devices have a rare potential for reduced or no-energy output during high-voltage therapy, typically in the 0-12 joule range. This could prevent the device from delivering defibrillation when needed.
The devices were distributed nationwide and worldwide. Patients should contact their healthcare provider or Medtronic to determine if their device is affected and discuss appropriate next steps.
No illnesses or injuries have been reported.
The recalled product
- Product
- CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
- Affected units
- 2,173
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 00643169837683
- Lot Serial Numbers: RPU202561H
- RPU202848H
- RPU202573H
- RPU203658H
- RPU203285H
- RPU203317H
- RPU203431H
- RPU203502H
- RPU203716H
- RPU203301H
- RPU203534H
- RPU203203H
- RPU203261H
- RPU203298H
- RPU203066H
- RPU203286H
- RPU202440H
- RPU202452H
- RPU202505H
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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