FDA recall Z-0132-2025

Product

Vanta Implantable Neurostimulator (INS), Model 977006

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-08-21

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2025