Nevro® SADP2008-25BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813426020091), received between Sep 27, 2021 and Feb 16, 2024 — classified as 2 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 16, 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.

• InjuryFeb 16, 2024Adverse 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 FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE PATIENT RECEIVED ORAL ANTIBIOTICS. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18722187 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT THE PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS GIVEN ANTIBIOTICS AND CONTINUES TO USE THEIR DEVICE WITH EFFECTIVE PAIN RELIEF.

  Patient problems: Unspecified Infection

  MAUDE report 12537395 ↗