Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Reported: April 27, 2022 Initiated: March 10, 2022 #Z-0988-2022
Product Description
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Reason for Recall
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.
Details
- Recalling Firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Units Affected
- 1
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
- Location
- Sylmar, CA
Frequently Asked Questions
What product was recalled? ▼
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q. Recalled by St. Jude Medical, Cardiac Rhythm Management Division. Units affected: 1.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 27, 2022. Severity: Moderate. Recall number: Z-0988-2022.
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