Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Summary
The FDA issued a Class II for Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q by St. Jude Medical, Cardiac Rhythm Management Division. Reason: Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of .
Details
Source
Device Recall
External ID
Z-0989-2022
Action Date
2022-04-27
Status
Ongoing
Category
device
Product Description
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Lot/Code Info: REF# CDVRA500Q SN: 111009251, Exp Date : 31-Jul-2022, Material # 100173801; SN # 810000544, Exp Date: 31-Oct-2022, Material # 600115400 UDI# 05415067031990
Quantity Affected: 2
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, KY and the country of France, Czech Republic.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-10
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 403 device-related FDA actions this month.
St. Jude Medical, Cardiac Rhythm Management Division has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical, Cardiac Rhythm Management Division) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical, Cardiac Rhythm Management Division have FDA actions?
St. Jude Medical, Cardiac Rhythm Management Division has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0989-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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