Open, Classified

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

FDA Recall Z-1123-2022 · Posted 2022-05-23

Recall StatusOpen, Classified

Product CodeLGW

Date Initiated2022-03-30

Product Quantity1021 devices

Reason for Recall

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

Firm Action

A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is paired with the patient's INS. If the INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments, the consignee is to contact Medtronic Technical Services. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm. Medtronic will be notifying consignees and actively retrieving any unused Vanta INS devices that contain the previous firmware version (as of 03-December-2025). Consignees will be asked to sign and return a confirmation form if applicable by region.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germany, Switzerland, Ireland, Croatia, Norway.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.