Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Su

FDA device recall Z-1123-2022 · posted 2022-05-23 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

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

Status

Open, Classified

Product code

LGW

Quantity affected

1021 devices

Distribution

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,

Date initiated

2022-03-30

Date posted

2022-05-23

Location

Minneapolis, MN