Recall Z-0990-2022— St. Jude Medical, Cardiac Rhythm Management Division
Class II · Ongoing
Class II FDA medical device recall by St. Jude Medical, Cardiac Rhythm Management Division, initiated 2022-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q. Reason: 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..
- Recalling firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-10
- Firm location
- Sylmar, CA, United States
Product description
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.