Recall Z-0912-2023— Medtronic Neuromodulation

Name: FDA recall Z-0912-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-03

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-12-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B. Reason: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303".

Recalling firm: Medtronic Neuromodulation
Classification: Class II
Status: Ongoing
Initiated: 2022-12-03
Firm location: Minneapolis, MN, United States

Product description

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.