St. Jude Medical, Cardiac Rhythm Management Division: Medical Device Recall in 2022 - (Recall #: Z-0989-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

Product Classification:

Class II

Date Initiated: March 10, 2022

Date Posted: April 27, 2022

Recall Number: Z-0989-2022

Event ID: 89825

Reason for Recall:

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

Status: Ongoing

Product Quantity: 2

Code Information:

REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated