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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0988-2022 |
Event ID | 89825 |
Event Description | Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. |
Quantity | 1 |
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. |
Device Classification | 20220427 |
Device Code Info | REF# CDDRA500Q SN# 111018237, Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003 |
Center Classification Date | 20220421 |
Recall Initiation Date | 20220310 |
Recalling Firm | St. Jude Medical, Cardiac Rhythm Management Division |
Initial Notification | Letter |
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