RecallRadar

FDA Device recall Z-1123-2022

Vanta INS Implantable Neurostimulator

On 2022-06-01 the FDA classified a Class II recall of Vanta INS Implantable Neurostimulator by Medtronic Neuromodulation, citing the Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1123-2022
ClassificationClass II
Statusongoing
Initiated2022-03-30
Published2022-06-01
Last updated2026-09-13 11:56 UTC
CompanyMedtronic Neuromodulation
DistributionUS

Product

Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.

Reason

The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

Identifiers

code_info
Model 977006 1) GTIN/UPN: 00763000518615: Expiration Date: 03/14/2023; Serial Numbers: NMS500202H, NMS500236H, NMS500…Model 977006 1) GTIN/UPN: 00763000518615: Expiration Date: 03/14/2023; Serial Numbers: NMS500202H, NMS500236H, NMS500243H, NMS500248H, NMS500253H, NMS500261H, NMS500262H, NMS500265H, NMS500266H, NMS500267H, NMS500269H, NMS500270H, NMS500271H, NMS500272H, NMS500273H, NMS500274H, NMS500275H, NMS500276H, NMS500277H, NMS500278H, NMS500279H, NMS500280H, NMS500282H, NMS500283H, NMS500285H, NMS500286H, NMS500287H, NMS500288H, NMS500289H, NMS500291H, NMS500292H, NMS500293H, NMS500294H, NMS500295H, NMS500296H, NMS500297H, NMS500298H, NMS500299H, NMS500300H, NMS500301H, NMS500302H, NMS500303H, NMS500304H, NMS500305H, NMS500306H, NMS500307H, NMS500308H Expiration Date: 04/14/2023; Serial Numbers: NMS500493H, NMS500494H, NMS500495H, NMS500496H, NMS500497H, NMS500498H, NMS500499H, NMS500500H, NMS500501H, NMS500502H, NMS500503H, NMS500504H, NMS500505H, NMS500506H, NMS500507H, NMS500508H, NMS500509H, NMS500510H, NMS500511H, NMS500512H Expiration Date: 09/14/2023; Serial Numbers: NMS501860H,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1123-2022%22

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