Gallant DR Implantable Cardioverter Defibrillator Bluetooth Malfunction Affects Remote Monitoring
St. Jude Medical's Gallant DR implantable cardioverter defibrillator has a Bluetooth malfunction preventing remote monitoring and reducing battery life. The device enters inductive-only telemetry mode, requiring in-clinic monitoring instead.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall affects a critical life-saving device with a functional defect that impairs remote monitoring capability. Loss of remote monitoring for an implantable cardioverter defibrillator constitutes a risk-of-harm situation, even though no illnesses or injuries have been reported.
Plain-English summary
St. Jude Medical, Cardiac Rhythm Management Division, is recalling the Gallant DR Implantable Cardioverter Defibrillator (REF# CDDRA500Q) due to a Bluetooth malfunction. The defect causes the device to enter an inductive-only telemetry mode, resulting in loss of Bluetooth communication capability.
The primary impact is the inability to remotely monitor these devices. Instead of remote communication, patients must visit their healthcare provider's clinic or office for device monitoring and checks.
Additionally, the Bluetooth malfunction results in reduced battery longevity in affected devices. No illnesses or injuries have been reported in connection with this defect.
Patients with an affected device should contact their healthcare provider to discuss monitoring options and any appropriate follow-up care.
The recalled product
- Product
- Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
- Manufacturer
- St. Jude Medical, Cardiac Rhythm Management Division
- Hazard
- bluetooth-malfunction
- loss-of-remote-monitoring
- reduced-battery-longevity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF# CDDRA500Q SN# 111018237
- Exp Date: 31-Oct-2022 Material# 600115496 UDI# 05415067032003
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27