Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
This recall is currently active, issued March 10, 2022. It was issued by St. Jude Medical, Cardiac Rhythm Management Division.
- Recall Initiated
- March 10, 2022
- Recall Number
- Z-0990-2022
- Quantity
- 1
- Firm Location
- Sylmar, CA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
REF# CDHFA500Q SN #111004346, Exp Date : 30-Jun-2022 Material # 100173746 UDI: 05415067032010
Root Cause
Component design/selection
Action Taken
Abbott issued a Safety Notification For a subset of Gallant ICDS and CRT-D, Models CDVRA500Q, CDDRA500Q and CDHFA500Q on March 10, 2022. Notification was hand delivered in US. The notification includes the Patient Management Recommendations: -As the devices are unable to be followed using remote monitoring via Bluetooth connectivity, follow-ups should be conducted in-clinic using inductive telemetry. - Abbott has developed a process to attempt recovery of Bluetooth communication via a device firmware upgrade. If remote monitoring via Bluetooth communication is desired, please work with your local Abbott representative to schedule a firmware upgrade. Please complete and return the included Acknowledgement Form to CRMNotification@abbott.com and maintain a record of this notice to ensure effectiveness of the communication. For any question, please contact Abbott Technical Support at 1-800-722-3774 (U.S.).