Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Check against the official notice below — it lists the full affected range.
St. Jude Medical has recalled two Gallant VR Implantable Cardioverter Defibrillator devices due to a Bluetooth malfunction that can occur after implantation. When this malfunction occurs, the device switches to an inductive-only telemetry mode, which prevents remote monitoring and causes the battery to drain faster than normal.
The two affected devices were distributed worldwide, with US distribution in Florida and Kentucky, as well as distribution in France and the Czech Republic. The record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. Quantity: 2 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.