St. Jude Medical, Cardiac Rhythm Management Division recalls Gallant DR Implantable Cardioverter Defibrillator REF # CDD
Recalled Product
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
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
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