Z-0913-2023Class II

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

Name: Z-0913-2023 Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number...
Creator: Medtronic Neuromodulation
Published: 2022-12-03
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2022-12-03 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C on 2022-12-03. FDA classified it as Class II and gives the reason as "Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0913-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-03
Posted: 2023-01-06
Recalling firm: Medtronic Neuromodulation
Product: Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Root cause tag: software
FDA 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 in commerce: 18 units
Distribution: Worldwide distribution.
Product codes and lots: GTIN 00643169890961: Lot/Serial Numbers: NPL1000794, NPL1002295, NPL1002284, NPL1002272, NPL1001670, NPL1001615, NPL1001596, NPL1001588, NPL1001591, NPL1001592, NPL1001583, NPL1001579, NPL1001558, NPL1000777, NPL1000774, NPL1000776, NPL1000453, NPL1000429.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0913-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0911-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0912-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0913-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0914-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0915-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)