St. Jude Medical, Cardiac Rhythm Management Division: Gallant DR Implantable
Recall reason: 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.. Recalled by St. Jude Medical, Cardiac Rhythm Management Division. Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.. Classification (Class II — potential health risk). Affected lots/dates: REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003. Contact th
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