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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