Implantable Defibrillators May Fail to Deliver Therapy in Rare Cases
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may rarely fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough.
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: This is FDA Class I, which mandates a minimum severity score of 4. The device malfunction represents a potential threat to life due to the device's critical cardiac function, despite no documented reported deaths or injuries in the source material.
Plain-English summary
Medtronic Inc. is recalling 10,370 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) model DTMB1QQ AMPLIA MRI QUAD US DF4. The devices contain a rare potential defect affecting a specific feedthrough component.
Affected devices may produce reduced or no energy output during high-voltage therapy, typically delivered at 0-12 joules. This malfunction could prevent the device from delivering needed therapy to correct dangerous heart rhythms.
The recall affects devices distributed nationwide and worldwide. Specific lot serial numbers are identified in the FDA recall database.
Patients who have received these devices should contact Medtronic or their healthcare provider for information about whether their device is affected and what steps they should take.
The recalled product
- Product
- CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators
- Affected units
- 10,370
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 00643169720671
- Lot Serial Numbers: RPE221706H
- RPE221707H
- RPE221708H
- RPE221712H
- RPE221714H
- RPE221715H
- RPE222453H
- RPE222479H
- RPE222484H
- RPE222493H
- RPE223082H
- RPE223083H
- RPE223085H
- RPE223086H
- RPE223087H
- RPE224112H
- RPE224115H
- RPE224116H
- RPE224117H
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
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- HighMedtronic Implantable Defibrillators Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- CriticalMedtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
FDA (Devices) · 2018-02-28
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28
- SevereMedtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect
FDA (Devices) · 2022-08-17
- HighMedtronic Implantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- HighImplantable defibrillator recalled for manufacturing defect causing device failure risk
FDA (Devices) · 2024-07-03