Nevro® LEAD2008-35B (UDI 00813426020831)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813426020831), received between Jun 17, 2025 and Apr 30, 2026 — classified as 3 injuries.

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

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING FOLLOWING THE TRIAL PADDLE PROCEDURE. THE CAUSE OF THE BLEEDING IS UNKNOWN. THE PATIENT REQUIRED MEDICAL INTERVENTION IN THE HOSPITAL AND ALSO RECEIVED INTRA-PROCEDURAL INTERVENTIONS TO ADDRESS THE EVENT. THE ISSUE WAS RESOLVED, AND THE PATIENT IS CURRENTLY IMPLANTED AND REPORTEDLY DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25049045 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A BACTERIAL INFECTION AND DEVELOPED SEPSIS. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 24712583 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE LEAD INCISION SITE. A MEDICAL ASSESSMENT REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE LEAD ADAPTORS AND LEAD EXTENSIONS WERE REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22255416 ↗