Implantable Defibrillators May Fail to Deliver Energy During Therapy
Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.
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 per agency classification. No deaths, serious injuries, or reported illnesses are documented in the source. The mandatory minimum for Class I devices is Severe, reflecting the potential for therapy failure during critical cardiac events.
Plain-English summary
Medtronic is recalling specific lots of CRTD DTMB1D1 AMPLIA MRI US DF1 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The affected devices were manufactured with a specific glassed feedthrough component. Approximately 3,005 units have been distributed nationwide and worldwide.
The defect creates a rare potential for reduced or complete loss of energy output during high voltage therapy, typically 0-12 joules. If this occurs, the device may not deliver therapy when needed.
Patients with affected devices are at potential risk. Healthcare providers have received notification with specific lot numbers for identifying affected devices. Patients who may be affected should contact their cardiologist or device clinic immediately to determine if their device is involved. They should not discontinue use without medical guidance, as Medtronic and healthcare providers work to distribute detailed information and determine appropriate next steps.
The recalled product
- Product
- CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
- Affected units
- 3,005
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 00643169837690
- Lot Serial Numbers: RPV203851H
- RPV203879H
- RPV204192H
- RPV204308H
- RPV205279H
- RPV205423H
- RPV205665H
- RPV205443H
- RPV205510H
- RPV204476H
- RPV205107H
- RPV204152H
- RPV204326H
- RPV204327H
- RPV204329H
- RPV203937H
- RPV204831H
- RPV204911H
- RPV205343H
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 · energy output failure
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic CRT-D and ICD Defibrillators Recalled for Potential Therapy Output Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators Recalled for Potential High Voltage Therapy Failure
FDA (Devices) · 2023-06-28
- SevereImplantable defibrillators risk energy output failure during high voltage therapy
FDA (Devices) · 2023-06-28
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