Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q Recalled by St. Jude Medical, Cardiac Rhythm Management Division Due to Bluetooth malfunction impacting Gallant devices post-implant. The failure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical, Cardiac Rhythm Management Division directly.
Affected Products
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Quantity: 2
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About St. Jude Medical, Cardiac Rhythm Management Division
St. Jude Medical, Cardiac Rhythm Management Division has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report