ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Reported: June 28, 2023 Initiated: May 10, 2023 #Z-1716-2023
Product Description
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Reason for Recall
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 37,547 units
- Distribution
- US Nationwide - Worldwide Distribution
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 37,547 units.
Why was this product recalled? ▼
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2023. Severity: Critical. Recall number: Z-1716-2023.
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