Recall Z-0990-2022 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St. Jude Medical, Cardiac Rhythm Management Division
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
| Date | Mar 10, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 1 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.