Vanta Implantable Neurostimulator (INS), Model 977006

FDA device recall Z-0132-2025 · posted 2024-10-17 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

Action taken

Medtronic issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 08/21/2024 via letter and email. The notice explained the issue, recommended mitigation, and requested the following: Required Actions: " Ensure that the Device Eligibility screen in the Model A71300 Clinician Programmer application is used during the trialing evaluation to review compatible INSs that will allow the same parameters used during the trial evaluation. " Ensure that the battery longevity tools in the Model A71200 Clinician Programmer application are used during each patient visit, to keep track of the estimated longevity of the Vanta INS. " Ensure that the patient understands the impact of therapy changes on the battery life of the Vanta INS. " Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LGW

Quantity affected

11789 units

Distribution

Worldwide distribution.

Date initiated

2024-08-21

Date posted

2024-10-17

Location

Minneapolis, MN