The FDA has posted 5 enforcement recalls of totally implanted for pain relief spinal-cord stimulator devices since 2025, none of them Class I (most serious). Most recent report: Jun 17, 2026.
Sterile anchors my lack sterility assurance.
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain sympt…
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Stimulator, Spinal-Cord, Totally Implanted For Pain Relief”). Informational only — verify against the FDA before acting.