Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

FDA device recall Z-0915-2023 · posted 2023-01-06 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Action taken

The firm issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/03/2022 by mail. The notices explained the problems and the associated risks and provided the following: "Recommended Mitigation If the INS cannot be interrogated with Vanta PP App, contact Medtronic Technical Services at 1-800-707-0933. If needed, Medtronic will schedule an in-field service appointment with the managing SCS physician and the patient to diagnose and reset the INS." "Medtronic is working on a Vanta CP App software update that will resolve this issue and will communicate additional information when it becomes available."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

22 units

Distribution

Worldwide distribution.

Date initiated

2022-12-03

Date posted

2023-01-06

Location

Minneapolis, MN