Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2023 - (Recall #: Z-1809-2023)

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 DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators

Product Classification:

Class I

Date Initiated: May 10, 2023

Date Posted: June 28, 2023

Recall Number: Z-1809-2023

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: 20 units

Code Information:

GTIN 00643169720558, Lot Serial Numbers: PKZ212063H, PKZ212047H, PKZ212048H, PKZ212049H, PKZ212050H, PKZ212055H, PKZ212061H, PKZ212062H, PKZ212042H, PKZ212039H, PKZ212041H, PKZ212027H, PKZ212032H, PKZ212033H, PKZ212035H, PKZ212044H, PKZ212053H, PKZ212054H, PKZ212056H, PKZ212057H

Distribution Pattern:

US Nationwide - Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated