Accurian APSC02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000153458), received between Mar 3, 2022 and Oct 30, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K181864); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE USING THE ACCURIAN ENHANCED RADIOFREQUENCY (RF) PROBE WITH A TREATMENT SITE OF THE FEMORAL NERVE. INITIALLY AN ISSUE OCCURRED DESCRIBED AS A FEMORAL NERVE INJURY AND SUBSEQUENTLY UPDATED TO A BURN. THE PATIENT IS STILL UNDER TREATMENT FOR THE INJURY. STANDARD TREATMENT THERAPY WAS ADMINISTERED, AND PRE-LOADED SETTINGS WITHIN THE ACCURIAN GENERATOR WERE USED. EDUCATION WAS PROVIDED PRIOR TO THE PROCEDURE, AND THE UNIT PERFORMING RF ABLATION CONDUCTS PROCEDURES MULTIPLE TIMES PER WEEK. THE STANDARD ENHANCED WORKFLOW WAS FOLLOWED. IT IS BELIEVED THE ISSUE MAY HAVE BEEN DUE TO A SECONDARY TRANSFER OF ENERGY DUE TO THE PATIENT HAVING A KNEE REPLACEMENT ON THE TREATMENT SIDE. A DIATHERMY PAD WAS PLACED ON THE OPPOSITE SIDE. INFORMATION WAS RECEIVED AGAIN INDICATING A POSSIBLE NERVE INJURY.

  Patient problems: Burn(s); Nerve Damage

  MAUDE report 23424974 ↗
• MalfunctionMar 3, 2022Defective Device

  DURING LEFT KNEE GENICULAR NERVE ABLATION THE ACCURIAN ENHANCED RF PROBE WAS NOT FUNCTIONING CORRECTLY. AFTER TWO ATTEMPTS THE PROBE WAS REMOVED AND NEW PROBE KIT OPENED. DEFECTIVE PROBE AND PRODUCT INFORMATION SAVED.

  Patient problems: Insufficient Information

  MAUDE report 13659121 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181864. One submission often covers many models, so check the product and lot details in each record.

• Z-2692-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2691-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007 GTIN / UPN: 20763000153568 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2693-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012 GTIN / UPN: 20763000153629 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2695-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019 GTIN / UPN: 20763000153667 - Product Usage: (sterile, single-use) comprises an electrically
• Z-2690-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically i
• Z-2694-2020 · Jun 8, 2020 · Terminated
  Accurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016 GTIN / UPN: 20763000153674 - Product Usage: (sterile, single-use) comprises an electrically i