Medtronic Neuromodulation Vanta Implantable Neurostimulator (INS), Model 977006 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.