Gallant VR Implantable Cardioverter Defibrillator Bluetooth malfunction impairs remote monitoring
Certain Gallant VR Implantable Cardioverter Defibrillator units experience Bluetooth malfunction preventing remote monitoring and reducing battery longevity.
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 is a Class II recall of an implantable cardiac device affecting critical monitoring and battery function. No injuries or illnesses reported; classified as risk-of-harm product where functional defect has not yet caused reported harm.
Plain-English summary
St. Jude Medical has recalled certain Gallant VR Implantable Cardioverter Defibrillator units (REF# CDVRA500Q) due to a Bluetooth malfunction that occurs after device implantation. The recall involves serial numbers 111009251 (expiration July 31, 2022) and 810000544 (expiration October 31, 2022).
The Bluetooth malfunction causes the device to enter an inductive-only telemetry mode, resulting in loss of Bluetooth communication. Consequently, the device cannot be remotely monitored and experiences reduced battery longevity.
The recall affects two devices distributed worldwide, with US distribution in Florida and Kentucky, as well as France and Czech Republic. Patients with affected devices should contact St. Jude Medical or their healthcare provider regarding evaluation and management options.
The recalled product
- Product
- Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
- Manufacturer
- St. Jude Medical, Cardiac Rhythm Management Division
- Category
- Medical Device — Cardiac Device
- Hazard
- bluetooth-malfunction
- remote-monitoring-failure
- battery-degradation
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 (6)
- REF# CDVRA500Q SN: 111009251
- Exp Date : 31-Jul-2022
- Material # 100173801
- SN # 810000544
- Exp Date: 31-Oct-2022
- Material # 600115400 UDI# 05415067031990
Distribution
Distributed nationwide across the United States.
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