Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2023 - (Recall #: Z-1796-2023)
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 DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Product Classification:
Class I
Date Initiated: May 10, 2023
Date Posted: June 28, 2023
Recall Number: Z-1796-2023
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: 4 units
Code Information:
GTIN 00643169720435, Lot Serial Number: BWH224619H, BWH224621H, BWH224620H, BWH224623H
Distribution Pattern:
US Nationwide - Worldwide Distribution
Voluntary or Mandated:
Voluntary: Firm initiated