Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Energy Output Failure
Medtronic is recalling certain implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a rare potential for reduced or no energy output during high voltage therapy. Approximately 37,547 units are affected.
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 an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. The potential for reduced or absent energy output during critical high voltage therapy represents a serious health risk, as the device may fail to deliver necessary lifesaving treatment.
Plain-English summary
Medtronic is recalling the ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D). Approximately 37,547 units are affected, distributed nationwide and worldwide.
These devices contain a specific glassed feedthrough component that poses a rare potential for reduced or completely absent energy output during high voltage (HV) therapy, typically in the 0-12 joule range. This defect could prevent the device from delivering necessary therapy to correct abnormal heart rhythms.
Patients with these recalled implantable defibrillators should contact their healthcare provider to determine whether their device is affected using the recalled lot serial numbers and discuss appropriate monitoring or replacement options. Healthcare providers should review the affected lot serial numbers to identify impacted devices in their patient population.
The recalled product
- Product
- ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
- Affected units
- 37,547
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 00643169720527
- Lot Serial Numbers: PHZ203294H
- PHZ204099H
- PHZ202880H
- PHZ202731H
- PHZ203576H
- PHZ203873H
- PHZ202558H
- PHZ202949H
- PHZ203163H
- PHZ204430H
- PHZ203645H
- PHZ204171H
- PHZ204583H
- PHZ204585H
- PHZ204589H
- PHZ204600H
- PHZ204629H
- PHZ204676H
- PHZ204879H
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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