St. Jude Medical, Cardiac Rhythm Management Division Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Brand
St. Jude Medical, Cardiac Rhythm Management Division
Lot Codes / Batch Numbers
REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801, SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
Products Sold
REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
St. Jude Medical, Cardiac Rhythm Management Division is recalling Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q due to Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of B. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026