Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2023 - (Recall #: Z-1795-2023)

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 DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators

Product Classification:

Class I

Date Initiated: May 10, 2023

Date Posted: June 28, 2023

Recall Number: Z-1795-2023

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: 16 units

Code Information:

GTIN 00643169720466, Lot Serial Numbers: BWI218211H, BWI218218H, BWI218226H, BWI218228H, BWI218206H, BWI218224H, BWI218210H, BWI218222H, BWI218217H, BWI218214H, BWI218216H, BWI218208H, BWI218207H, BWI218221H, BWI218212H, BWI218220H

Distribution Pattern:

US Nationwide - Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated