Health product recall

Vanta Clinician Programmer Application

Brand(s)
Last updated

Summary

Product
Vanta Clinician Programmer Application
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Vanta Clinician Programmer Application

More than 10 numbers, contact manufacturer.

A71200

Issue

Notification to inform customers that in rare instances (0.085%) during initial programming, the Vanta CP app will display the error code 1502 message because the Vanta INS reset block id log is full. Once the log is full, all subsequent interrogations with the affected device will not be possible.
If the error code 1502 message occurs, it will display during the next interrogation after the Vanta INS usage is started. Should this present at initial programming:
• Surgery may be delayed to obtain an alternative INS, or surgery may be cancelled if an alternative INS is unavailable and the affected INS is not implanted.
• It will not be possible to program the device so therapy cannot be initiated for newly implanted patients and patients receiving a replacement device may experience a return of underlying pain symptoms.
• If the recommended cannot be performed, an unanticipated surgical intervention may be needed to explant and replace the INS.
The issue is related to the Vanta CP app. The Vanta INS is performing as intended. If the INS has been previously programmed, it will continue to provide therapy to the patient within programmed parameters.

Recall start date: August 2, 2022

Additional information

Details
Original published date: 2022-08-22
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Medtronic Inc.

710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64473