Coblation AC3525-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470004557), received between Feb 22, 2022 and Feb 22, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K033584); 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. 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.

• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON A POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) REVIEW PMCF FOR JOINT WANDS, DURING A KNEE PROCEDURE, 1 PATIENT HAD AN UNWANTED DAMAGED IN THE ARTICULAR CARTILAGE USING A 2.5MM DOME 60 DEGREE ICW WAND. ADDITIONALLY THE DR WAS UNABLE TO FULLY RESECT THE MENISCAL TEAR DUE TO LOCATION. THE PATIENT OUTCOME IS UNKNOWN. THE INFORMATION PROVIDED IS ANONYMIZED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN AND IT IS NOT POSSIBLE TO COLLECT IT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13579991 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033584. One submission often covers many models, so check the product and lot details in each record.

• Z-2309-2008 · Apr 9, 2008 · Terminated
  ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation access