Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2023 - (Recall #: Z-1801-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 10, 2023

Date Posted: June 28, 2023

Recall Number: Z-1801-2023

Event ID: 92328

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.

Status: Ongoing

Product Quantity: 21 units

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

Voluntary or Mandated:

Voluntary: Firm initiated