Implantable Cardiac Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic's ICD-VR DVME3D4 defibrillators are recalled due to a rare risk of reduced or no energy output during high-voltage therapy. The defect involves a specific feedthrough component and affects approximately 14,989 units 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 classification requires a minimum severity score of 4 per the rubric. Although no injuries or deaths are reported in the source text, the potential failure of a lifesaving cardiac device to deliver therapy during critical moments constitutes a severe hazard.
Plain-English summary
Medtronic Inc.'s ICD-VR DVME3D4 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific glassed feedthrough component are subject to an FDA Class I recall. Approximately 14,989 units have been distributed in the United States and worldwide.
There is a rare potential for reduced- or no-energy output during high-voltage (HV) therapy, typically ranging from 0 to 12 joules. If the device fails to deliver necessary therapy, it could prevent treatment of life-threatening abnormal heart rhythms and pose serious health risks to patients.
Patients who have received the affected ICD-VR DVME3D4 MIRRO MRI devices should consult with their healthcare provider or cardiologist to determine if their device is affected. Identification may be made through the device serial lot numbers provided in the recall notice.
Patients with an affected device should contact Medtronic or their implanting hospital immediately for evaluation and potential device replacement or corrective action. Do not discontinue use without consulting a physician, as this could present a direct health risk. Patients should follow their healthcare provider's guidance on the appropriate course of action.
The recalled product
- Product
- ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
- Affected units
- 14,989
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 00763000001629
- Lot Serial Numbers: CWR601226S
- CWR601747S
- CWR614516S
- CWR615056S
- CWR611693S
- CWR610177S
- CWR613808S
- CWR600732S
- CWR606430S
- CWR602651S
- CWR607356S
- CWR610310S
- CWR604045S
- CWR603303S
- CWR609623S
- CWR605872S
- CWR601687S
- CWR603211S
- CWR602807S
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 · therapy failure
See all →- HighImplantable Vagus Nerve Stimulation Device May Stop Delivering Therapy
FDA (Devices) · 2025-02-05
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighReplacement Lead Wires Recalled for Risk of Treatment Delivery Failure
FDA (Devices) · 2024-05-01
- HighOPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
FDA (Devices) · 2024-02-28
- SeverePercussionaire Distal Phasitron respiratory device with reservoir bag assembly defect recalled
FDA (Devices) · 2024-01-24
Similar recalls
- 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 Cardioverter Defibrillator Recalled for Manufacturing Weld Defect
FDA (Devices) · 2024-07-03
- HighMedtronic Implantable Cardioverter Defibrillator Recalled Due to Weld Crack Defect
FDA (Devices) · 2024-07-03
- SevereCrome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy
FDA (Devices) · 2022-08-17
- SevereMedtronic Recalls Visia AF MRI ICDs Due to Therapy Prevention Risk
FDA (Devices) · 2018-02-28