StimRouter Implantable Kit ST2-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00815962020016), received between Feb 17, 2022 and Jul 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A patient implanted with a Talisman Implant Kit on (b)(6) 2025 reported during a follow up appointment ((b)(6) 2026) that the incision was not fully healed. The StimRouter Implantable Lead and Lead Introducer Kit were utilized during the Talisman Implantation. Decision by the patient's physician was to leave the dissolvable stitch for wound closure in place. Redness and swelling increased. While in (b)(6), patient visited emergency room for worsening local symptoms. The patient was prescribed Clindamycin and recommended to return to Duke Pain Clinic for follow up care as well as a potential explant. The StimRouter Lead was explanted without issue (b)(6) 2026, however the TalisMann (Implantable Pulse Generator Kit) IPG became detached during the explant process. The patient was referred to the implanting physician for surgical excision of the TalisMann IPG in the OR. On (b)(6) 2026 the device was successfully excised.The implant of the TalisMann model TM-1000 PNS device utilized the StimRouter model ST2-1000 StimRouter Implantable Lead and Lead Introducer Kit, Sterile. This report is for the StimRouter model ST2-1000 StimRouter Implantable Lead and Lead Introducer Kit, Sterile. A se

  Patient problems: Erythema; Skin Infection; Skin Inflammation/ Irritation

  MAUDE report 50091205 ↗
• InjuryFeb 17, 2022Material Separation; Migration; Incomplete or Inadequate Connection; Material Separation; Migration; Incomplete or Inadequate Connection

  BIONESS RECEIVED A MEDWATCH REPORT FROM THE FDA ON 24 JAN 2022. AS REPORTED "WE IMPLANTED A BIONESS STIMROUTER DEVICE IN THE RIGHT SUPRASCAPULAR NERVE IN 2020, WHICH MIGRATED OUT OF THE SUPRASCAPULAR NOTCH. ON REMOVING THE ELECTRODE TODAY, WE CAREFULLY EXTRACTED THE PROXIMAL ASPECT, AND THE ELECTRODE BROKE IN HALF. SIGNIFICANTLY, MORE TIME AND DEEP TISSUE DISSECTION INTO THE SUPRASPINATUS REGION WAS REQUIRED TO EXTRACT THE FOREIGN BODY. PATIENT WAS HAVING SEVERE PAIN FOR THE LAST 9 MONTHS AND WILL HAVE A PROLONGED RECOVERY DUE TO THE LEAD EXTRACTION DIFFICULTY."

  Patient problems: Pain

  MAUDE report 13548820 ↗