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Recall Observatory FDA recall evidence

Device product

ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators

Z-1801-2023

May 10, 2023

Class I

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 92328
Status
Ongoing
Classification
Class I
Quantity
21 units
Official record key
device-enforcement:Z-1801-2023

Official wording

Reason: 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.

Code information: GTIN 00763000115647, Lot Serial Numbers: EVR600484S, EVR600487S, EVR600488S, EVR600489S, EVR600490S, EVR600492S, EVR600494S, EVR600479S, EVR600480S, EVR600483S, EVR600500S, EVR600495S, EVR600496S, EVR600478S, EVR600516S, EVR600517S, EVR600519S, EVR600521S, EVR600522S, EVR600525S, EVR600526S

Distribution pattern: US Nationwide - Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.