FDA recall Z-0989-2022

St. Jude Medical, Cardiac Rhythm Management Division · Class II · device

Product

Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q

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.

Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.

Key facts

Status: Ongoing
Initiation date: 2022-03-10
Report date: 2022-04-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sylmar, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2022