Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0988-2022.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0988-2022.
Recall ongoing. Follow firm instructions.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact St. Jude Medical, Cardiac Rhythm Management Division or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0988-2022.
St. Jude Medical, Cardiac Rhythm Management Division
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St. Jude Medical, Cardiac Rhythm Management Division Recall FAQ
St. Jude Medical, Cardiac Rhythm Management Division is the subject of a medical implants safety report: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q. The notice was published on March 10, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 1 units are potentially affected.