Gallant VR Implantable Cardioverter Defibrillator recall
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Why was Gallant VR Implantable Cardioverter Defibrillator recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
- Product
- Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
- Recalling firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Quantity
- 2
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
- Recall date
- April 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)