TalisMann Implant Kit TM-1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816986020549), received between Jun 29, 2026 and Jul 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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, 2026Break; Adverse 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 NY, patient visited emergency room for worsening local symptoms. The patient was prescribed Clindamycin and recommended to return to (b)(6) 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 operating room. 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 TalisMann model TM-1000 PNS device. A seperate report is submitted for the ST2-1000 StimRouter

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

  MAUDE report 50091206 ↗
• InjuryJun 29, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Lack of Effect

  PATIENT EXPERIENCED LOCALIZED PAIN AND DISCHARGE APPROXIMATELY 10 DAYS POST IMPLANT OF THE STIMROUTER PNS DEVICE. THE PATIENT ALSO EXPERIENCED A LACK OF PAIN RELIEF FROM STIMULATION. THE PATIENT SENT PHOTOS TO THE SALES REP AND THE PHYSICIAN WHO PRESCRIBED KEFLEX AT A FREQUENCY OF FOUR TIMES PER DAY. AT THE PATIENTS IN PERSON FOLLOW-UP APPOINTMENT, THE PHYSICIAN RECOMMENDED AN EXPLANT DUE TO AN INFECTION AROUND THE LEAD, WHICH THE PATIENT DID NOT WANT AT THAT TIME. THE PHYSICIAN AND THE PATIENT DECIDE TO INCREASE THE INCISION SITE TO ALLOW FOR DRAINAGE AND PRESCRIBED A NEW ORAL ANTIBIOTIC TO CONTROL THE INFECTION AND SALVAGE THE IMPLANT. 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 TALISMANN MODEL TM-1000 PNS DEVICE.

  Patient problems: Inadequate Pain Relief; Pain; Skin Infection

  MAUDE report 25654431 ↗