Nevro® ACCK1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00813426020183), received between Jan 8, 2016 and Sep 5, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2018Detachment of Device or Device Component

  IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING THE TRIAL PROCEDURE. THE PHYSICIAN WAS ABLE TO REMOVE THE INSERTION NEEDLE WITHOUT INCIDENT. THE PROCEDURE WAS COMPLETED WITH NO FURTHER REPORTS OF COMPLICATIONS AND THE PATIENT HAD A SUCCESSFUL TRIAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844964 ↗
• MalfunctionFeb 28, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING A TRIAL PROCEDURE. IT OCCURRED WHEN THE PHYSICIAN WAS REMOVING THE NEEDLE FOLLOWING LEAD PLACEMENT. THE PHYSICIAN WAS ABLE TO REMOVE THE INSERTION NEEDLE WITHOUT INCIDENT. THE TRIAL WAS COMPLETED WITH NO FURTHER REPORT OF COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7305355 ↗
• MalfunctionJul 3, 2017Detachment Of Device Component

  IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING A TRIAL PROCEDURE. IT OCCURRED WHEN THE PHYSICIAN WAS REMOVING THE NEEDLE FOLLOWING LEAD PLACEMENT. THE PHYSICIAN WAS ABLE TO REMOVE THE INSERTION NEEDLE WITHOUT ANY INJURIES TO PATIENT. THE TRIAL WAS COMPLETED WITH NO FURTHER REPORT OF COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6684274 ↗
• MalfunctionMay 3, 2017Detachment Of Device Component

  IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING A TRIAL PROCEDURE. IT OCCURRED WHEN THE PHYSICIAN WAS REMOVING THE NEEDLE FOLLOWING LEAD PLACEMENT. THE PHYSICIAN WAS ABLE TO REMOVE THE INSERTION NEEDLE WITHOUT INCIDENT. THE TRIAL WAS COMPLETED WITH NO FURTHER REPORT OF COMPLICATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541890 ↗
• MalfunctionDec 27, 2016Detachment Of Device Component

  IT WAS REPORTED TO NEVRO THAT THE INSERTION NEEDLE DETACHED FROM THE HUB DURING A PERMANENT PROCEDURE. THE DETACHED NEEDLE WAS RETRIEVED WITH NO HARM TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6205847 ↗
• InjuryJan 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NEVRO THAT A PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEVERE HEADACHE POST IMPLANT. THE PHYSICIAN INDICATED THAT HE HAD A WET TAP USING A 6" NEEDLE. THE PATIENT RECEIVED A BLOOD PATCH AND THE HEADACHE WAS RESOLVED. THE REPORT INDICATED THAT PATIENT HAD RECOVERED WITHOUT SEQUELAE.

  Patient problems: Headache

  MAUDE report 5354104 ↗