Implantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Certain Medtronic implantable cardioverter defibrillators may fail to deliver high-voltage therapy due to a specific feedthrough defect. The 4,767 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: FDA Class I designation requires a minimum score of 4. This defect poses a serious patient safety risk by potentially preventing lifesaving high-voltage therapy delivery in critical cardiac situations, though no illnesses or deaths have been reported.
Plain-English summary
Medtronic Inc. is recalling certain CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough. This defect creates a rare potential for reduced or no-energy output during high-voltage (HV) therapy, typically when delivering 0 to 12 joules of energy.
The affected devices may fail to deliver adequate therapy to patients who depend on these implanted devices to treat life-threatening heart rhythms. A total of 4,767 units with specific lot serial numbers were distributed throughout the United States and worldwide.
Patients who have received one of the affected devices should contact Medtronic or their implanting cardiologist or electrophysiologist for guidance. Healthcare providers can identify potentially affected units using the provided lot serial numbers and determine whether device replacement or other clinical intervention is necessary.
The recalled product
- Product
- CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators
- Affected units
- 4,767
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 00643169837638
- Lot Serial Numbers: RPP602125S
- RPP602593S
- RPP603699S
- RPP602902S
- RPP602417S
- RPP601873S
- RPP602956S
- RPP601533S
- RPP603620S
- RPP600808S
- RPP603725S
- RPP602431S
- RPP602451S
- RPP602452S
- RPP602460S
- RPP602737S
- RPP602741S
- RPP602778S
- RPP602780S
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 →- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
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
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
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
- SevereMedtronic Visia AF ICDs Recalled for Potential Therapy Failure
FDA (Devices) · 2018-02-28
- 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
- HighMedtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- HighImplantable Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03