Paired VNS 3000 (UDI 10810041430066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10810041430066), received between Jul 24, 2023 and May 15, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL IMPLANTATION PROCEDURE FOR THE VIVISTIM SYSTEM, THE SURGEON IDENTIFIED ANATOMICAL LIMITATIONS INVOLVING THE PATIENT'S VAGUS NERVE THAT PREVENTED SAFE PLACEMENT OF THE HELICAL LEAD. THE VAGUS NERVE WAS REPORTED TO BE TOO SMALL FOR THE 2 MM HELICAL LEAD AND CONTAINED MULTIPLE BRANCHES THAT INTERFERED WITH LEAD PLACEMENT. THE IMPLANTING PHYSICIAN CONSULTED A COLLEAGUE INTRAOPERATIVELY TO CONFIRM IDENTIFICATION OF THE VAGUS NERVE, AND THE COLLEAGUE CONCURRED WITH THE ASSESSMENT. DUE TO THE PATIENT'S ANATOMY, THE IMPLANT PROCEDURE WAS ABORTED AND THE DEVICE WAS NOT IMPLANTED. NO DEVICE MALFUNCTION WAS IDENTIFIED. NO INJURY TO THE PATIENT WAS REPORTED AND THE PATIENT RECOVERED FROM THE PROCEDURE WITHOUT THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION RELATED TO THE EVENT. THE EVENT IS CONSIDERED RELATED TO PATIENT ANATOMY RATHER THAN DEVICE PERFORMANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186469 ↗
• InjuryFeb 6, 2026Use of Device Problem

  THE PATIENT UNDERWENT A SURGICAL POCKET REVISION PROCEDURE BECAUSE THE LEAD CONNECTOR BOOT WAS POSITIONED IN A MANNER THAT ITS SHAPE COULD BE SEEN BELOW THE SKIN. THE PATIENT HAD A COSMETIC CONCERN AND THE PHYSICIAN ALSO FELT THAT THERE MAY BE A RISK OF EROSION AT THAT AREA. THE POCKET REVISION WAS COMPLETED AND THE FINAL POSITION OF THE LEAD CONNECTOR BOOT WAS DEEPER AND MUCH LESS SUPERFICIAL THAN BEFOREHAND. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Musculoskeletal problem

  MAUDE report 24284761 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED COUGHING, HOARSENESS AND DIFFICULTY HAVING CONVERSATIONS POST IMPLANT. THE PATIENT FOLLOWED UP WITH IMPLANTING PHYSICIAN AND CONSULTED A VOICE DISORDER SPECIALIST. PER THE PATIENT, THEY HAD VOCAL CORD FILLER AND SYMPTOMS HAVE IMPROVED. DEVICE HISTORY RECORDS WERE REVIEWED FOR IPG S/N (B)(6) AND LEAD S/N (B)(6). THE DEVICES PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Cough; Paresis

  MAUDE report 17380118 ↗