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.
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: No illnesses or injuries reported and the hazard is theoretical (potential device malfunction without confirmed incidents). Per the severity rubric, theoretical hazards without reported harm score at most 3.
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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See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
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- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
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- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
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