Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2023 - (Recall #: Z-1791-2023)

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 VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators

Product Classification:

Class I

Date Initiated: May 10, 2023

Date Posted: June 28, 2023

Recall Number: Z-1791-2023

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: 71 units

Code Information:

GTIN 00643169720756, Lot Serial Numbers: BWR600821S, BWR600947S, BWR600936S, BWR600937S, BWR600941S, BWR600946S, BWR600959S, BWR601046S, BWR600938S, BWR601096S, BWR601093S, BWR600979S, BWR601092S, BWR600997S, BWR600934S, BWR600965S, BWR601050S, BWR601049S, BWR600823S, BWR601053S, BWR600983S, BWR600989S, BWR600984S, BWR601055S, BWR601057S, BWR601098S, BWR600822S, BWR600980S, BWR600981S, BWR600982S, BWR601097S, BWR601100S, BWR601095S, BWR601101S, BWR600991S, BWR601051S, BWR601058S, BWR601099S, BWR601094S; GTIN BWR601149S, BWR601155S, BWR601137S, BWR601138S, BWR601108S, BWR601113S, BWR601111S, BWR601119S, BWR601144S, BWR601146S, BWR601147S, BWR601148S, BWR601067S, BWR601150S, BWR601152S, BWR601115S, BWR601105S, BWR601112S, BWR601059S, BWR601061S, BWR601062S, BWR601063S, BWR601072S, BWR601073S, BWR601078S, BWR601081S, BWR601090S, BWR601116S, BWR601103S, BWR601075S, BWR601102S, BWR601104S

Distribution Pattern:

US Nationwide - Worldwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated