Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
This recall is currently active, issued January 6, 2023. It was issued by Medtronic Neuromodulation.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- December 3, 2022
- Posted
- January 6, 2023
- Recall Number
- Z-0915-2023
- Quantity
- 22 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Distribution
Worldwide distribution.
Lot / Code Info
GTIN 00763000447090: Serial/Lot Numbers: NPL3022869, NPL3022873, NPL3022049, NPL3022050, NPL3022795, NPL3022817, NPL3022190, NPL3022191, NPL3022052, NPL3022187, NPL3022193, NPL3022194, NPL3022195, NPL3022212, NPL3022213, NPL3022289, NPL3021964, NPL3022043, NPL3022044, NPL3022034, NPL3021984, NPL3021990
Root Cause
Under Investigation by firm
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."