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St. Jude Medical, Cardiac Rhythm Management Division Recall 89825

Description: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q

St. Jude Medical, Cardiac Rhythm Management Division Recall 89825 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0988-2022
Event ID89825
Event DescriptionGallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Quantity1
Recall ReasonBluetooth 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.
Device Classification20220427
Device Code InfoREF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003
Center Classification Date20220421
Recall Initiation Date20220310
Recalling FirmSt. Jude Medical, Cardiac Rhythm Management Division
Initial Notification Letter
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