Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Check against the official notice below — it lists the full affected range.
St. Jude Medical is recalling one Gallant DR Implantable Cardioverter Defibrillator (model CDDRA500Q, serial number 111018237) due to a Bluetooth malfunction that can occur after the device is implanted. When this malfunction occurs, the device switches to inductive-only telemetry mode and loses Bluetooth communication capability, preventing remote monitoring of the device and causing the battery to drain faster than normal.
The affected device was distributed worldwide, including in Florida, Kentucky, France, and the Czech Republic. The source record does not specify what an affected consumer should do or what remedy is available.
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: 1 Lot/code info: REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.