FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
- Recall number
- Z-0915-2023
- Recalling firm
- Medtronic Neuromodulation
- Product
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
- Status
- Open, Classified
- Initiated
- 2022-12-03
- Posted
- 2023-01-06
- Terminated
- not on file
- Reason
- Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- Root cause
- Under Investigation by firm
- Action
- 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."
- Quantity
- 22 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGW
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28