FDA-Device2022-04-27Class II
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Hazard
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.
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Affected count
2
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2022Don't want to check this manually?
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