medical Class II Updated 2022-04-27

St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant VR Implantable Cardioverter Defibrillator REF # CDV

Recalled Product

Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
View official government recall

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