Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
- Company
- Medtronic Neuromodulation
- Recall Initiated
- December 3, 2022
- Posted
- January 6, 2023
- Recall Number
- Z-0913-2023
- Quantity
- 18 units
- Firm Location
- Minneapolis, MN
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 00643169890961: Lot/Serial Numbers: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, NPL1000429.
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."