Nevro® ACCK5300Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00813426020251), received between Dec 8, 2016 and Jul 31, 2026 — classified as 33 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Fracture” (16 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. 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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient acquired an infection and developed an abscess at the anchor site. According to the medical assessment, the infection was not believed to be device related. The patient was treated with oral antibiotics, underwent a wound washout, and ultimately had the device removed. There have been no reports of further complications related to this event.

  Patient problems: Abscess; Insufficient Information; Unspecified Infection

  MAUDE report 50099840 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION ON THE LEAD ANCHOR SITE. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THE ENTIRE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 25331444 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND DEVELOP AN ABSCESS. ACCORDING TO THE MEDICAL ASSESSMENT, THE INFECTION IS NOT BELIEVED TO BE DEVICE-RELATED. THE PATIENT WAS HOSPITALIZED, TREATED WITH IV ANTIBIOTICS, AND THE ABSCESS WAS ASPIRATED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 24860412 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE ANCHOR SITE. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THE DOCTOR DID NOT FEEL IT WAS RELATED TO THE DEVICE DIRECTLY. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23595711 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A STAPHYLOCOCCUS EPIDERMIDIS INFECTION AT THE ANCHOR SITE. THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS DEVICE RELATED. THE PATIENT WAS HOSPITALIZED, UNDERWENT A REVISION SURGERY WITH WOUND WASHOUT, RECEIVED IV ANTIBIOTIC TREATMENT, AND HAD THE ANCHORS AND LEADS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23369158 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE POCKET SITE AND DISCOMFORT AT ANCHOR SITE. IT WAS BELIEVED THAT THE ANCHORS HAD MOVED, PROVOKING THE REPORTED ISSUES. THE PATIENT HAD THE DEVICE REMOVED. THERE HAVE BEEN NO FURTHER REPORTS OF COMPLICATIONS RELATED TO THIS EVENT.

  Patient problems: Discomfort; Implant Pain

  MAUDE report 23040330 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN ISSUES DUE TO THE ANCHOR. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22503847 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORRECTION: THE PATIENT ALSO RECEIVED A WOUND WASHOUT AS PART OF THE TREATMENT.

  Patient problems: Unspecified Infection

  MAUDE report 21318341 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN FROM THE ANCHOR SITE. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT'S DEVICE WAS REMOVED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 21203008 ↗
• MalfunctionNov 20, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ANCHOR WAS FOUND TO BE BROKEN INSIDE THE PATIENT'S BODY UPON A SURGICAL REVISION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DAMAGED ANCHOR WAS REMOVED AND REPLACED; MOST WAS RETRIEVED AS BEST AS THE CONSULTANT COULD. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20735954 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT AN ANCHOR WAS FOUND TO BE BROKEN INSIDE THE PATIENT'S BODY UPON A SURGICAL REVISION. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DAMAGED ANCHOR WAS REMOVED AND REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599300 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AT THE ANCHOR & LEAD INCISION SITE AND THAT THE PATIENT ALSO EXPERIENCED INADEQUATE WOUND HEALING. THE PATIENT RECEIVED ORAL ANTIBIOTICS AND HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 20136690 ↗
• MalfunctionJun 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE ANCHOR WAS FOUND BROKEN DURING A REVISION. IT WAS NOT CLEAR IF THE LEAD WAS FRACTURED AS WELL, BUT SEVERAL CONTACTS WERE NONFUNCTIONAL (HIGH IMPEDANCE VALUES) SO THE ANCHOR POSSIBLY FRACTURED THE LEAD. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618107 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S ANCHORS WERE ERODING OUT OF THE INCISION SITE WERE THERE WAS A BACTERIAL INFECTION. THE PATIENT HAD NO ISSUES WITH THERAPY SHE HAD GOOD RELIEF. THE PATIENT HAD THE DEVICE EXPLANTED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Bacterial Infection; Erosion

  MAUDE report 19345556 ↗
• MalfunctionMay 17, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ANCHOR WAS FOUND TO BE BROKEN INSIDE THE PATIENT'S BODY. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE DAMAGED ANCHOR WAS REMOVED AND REPLACED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19338349 ↗
• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN DUE TO LOOSE ANCHORS. AN HCP ASSESSMENT REGARDING THE CAUSE OF THE REPORTED EVENT WAS NOT AVAILABLE. THE PATIENT HAD THE DEVICE REVISED. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Pain

  MAUDE report 19249178 ↗
• InjuryDec 13, 2023Fracture; Insufficient Device Problem Information; Migration; Fracture; Insufficient Device Problem Information; Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS IN PAIN RELIEF DUE TO LEAD MIGRATION. A REVISION WAS PERFORMED. DURING THE REVISION THE ANCHOR WAS FOUND IN BODY CAVITY SEVERED IN HALF AND THE SET SCREW BOX WAS FREE FLOATING IN THE POCKET. THE HCP WAS ABLE TO SALVAGE ALL THE PARTS THAT WERE FREE FLOATING AND NOTHING WAS LEFT BEHIND. THE HCP REPLACED THE UPPER LEAD WITH HIGH IMPEDANCES AND WAS ABLE TO RESEAT THE LOWER LEAD BACK IN PLACE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18320312 ↗
• MalfunctionNov 1, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DEVELOPED A LUMP AT THE ANCHOR IMPLANTATION SITE. DURING REVISION, IT WAS DISCOVERED THAT THE ANCHOR HAD FRACTURED INTO TWO PIECES. THE PHYSICIAN REMOVED THE FRAGMENTS AND REPLACED THE ANCHOR. SUBSEQUENT X-RAY IMAGING CONFIRMED THAT THE SITE IS FREE OF FRAGMENTS. ALL PIECES WERE SUCCESSFULLY RETRIEVED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 18048457 ↗
• MalfunctionNov 1, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND DEVELOPED A LUMP AT THE ANCHOR IMPLANTATION SITE. DURING REVISION, IT WAS DISCOVERED THAT THE ANCHOR HAD FRACTURED INTO TWO PIECES. THE PHYSICIAN REMOVED THE FRAGMENTS AND REPLACED THE ANCHOR. SUBSEQUENT X-RAY IMAGING CONFIRMED THAT THE SITE IS FREE OF FRAGMENTS. ALL PIECES WERE SUCCESSFULLY RETRIEVED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 18048438 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S WOUND OPENED UP AND WAS POSSIBLY INFECTED. IT IS BELIEVED BY THE PROVIDER THAT THE ANCHOR, OR AN ANCHOR SUTURE WAS PRESSING AGAINST THE ANCHOR INCISION SITE AND CAUSING IT TO REMAIN OPEN. THE PATIENT WAS SCHEDULED FOR A REVISION/DEBRIDEMENT PROCEDURE. UPON EXPOSING THE DEVICE, AN INFECTION WAS CONFIRMED AND THE PHYSICIANS DECIDED TO REMOVE THE IMPLANTED SYSTEM. DURING THE EXPLANT, AND LIKELY DUE TO THE INFECTION, THE ANCHORS WERE FOUND TO NO LONGER BE CONNECTED APPROPRIATELY. BOTH INVOLVED PHYSICIANS DID NOT BELIEVE THE INFECTION TO BE RELATED TO THE DEVICE. THE EXPLANT WAS COMPLETED SUCCESSFULLY AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT. THE PATIENT PLANS TO PURSUE RE-IMPLANTATION AFTER THE SITE HAS HEALED.

  Patient problems: Wound Dehiscence

  MAUDE report 17666128 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED AN INFECTION AND BECAME SEPTIC, THE PATIENT HAD TO BE HOSPITALIZED. A MEDICAL ASSESSMENT FROM THE PHYSICIAN REGARDING THE NATURE OF THE INFECTION WAS NOT AVAILABLE. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 16818276 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEROMA AT THE ANCHOR SITE AND IPG SITE. THE PHYSICIAN DRAINED THE SEROMA AT BOTH THE ANCHOR SITE AND IPG SITE AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Seroma

  MAUDE report 16778006 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. THE DEVICE WAS REMOVED AND THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 16652116 ↗
• InjuryMar 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. THE ANCHOR WAS REPLACED. THE ANCHOR WAS RECEIVED DAMAGED WITH ONE OF THE EYELETS CUT OFF AND MISSING. THE PHYSICIAN DIDN¿T MENTION REMOVING IT OR LEAVING IT IN SITU DURING THE PROCEDURE, HOWEVER THE EXACT LOCATION OF THE EYELET IS UNKNOWN. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 16570170 ↗
• InjuryMar 18, 2023Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE ANCHOR SITE. THE ANCHOR WAS REPLACED. THE ANCHOR WAS RECEIVED DAMAGED WITH ONE OF THE EYELETS CUT OFF AND MISSING. THE PHYSICIAN DIDN¿T MENTION REMOVING IT OR LEAVING IT IN SITU DURING THE PROCEDURE, HOWEVER THE EXACT LOCATION OF THE EYELET IS UNKNOWN. THERE HAVE BEEN NO REPORTS OF FURTHER COMPLICATIONS REGARDING THIS EVENT.

  Patient problems: Implant Pain

  MAUDE report 16569626 ↗