Nevro® ACCK8012-70Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813426020312), received between Sep 5, 2018 and Sep 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO NEVRO THAT THE STYLET TIP BROKE OFF WHEN THE STYLET WAS REMOVED FROM THE LEAD DURING AN IMPLANT PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE STYLET TIP WITHOUT INCIDENT. NO INJURIES WERE SUSTAINED BY THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER REPORTS OF COMPLICATIONS AND THE PATIENT IS CURRENTLY RECEIVING EFFECTIVE PAIN RELIEF FROM THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844968 ↗