Coblation AC2430-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817470004540), received between May 14, 2018 and Aug 12, 2021 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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

• InjuryAug 12, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SHOULDER CLEANING THE ELECTRODE OF THE BEVEL 45 ICW WAND FELL OFF. THERE WAS A S+N BACK-UP DEVICE AVAILABLE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316844 ↗
• InjuryJan 28, 2021Activation Problem; Activation Problem

  IT WAS REPORTED THAT, DURING A HIP SURGERY, THE BEVEL 45 WAND DID NOT WORK WHEN COAGULATING VESSELS. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A DIFFERENT WAND AS A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244542 ↗
• InjuryJan 8, 2021Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY WITH A WAND, THE PATIENT'S SHOULDER WAS SCALDED BY WATER ON THE LATERAL SIDE OF THE JOINT. THE WATER HAD FLOWED OUT FROM EQUIPMENT CONNECTION PIPELINE. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. THE PATIENT IS CURRENTLY UNDERGOING FOLLOW-UP TREATMENT. NO FURTHER WERE COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11140704 ↗
• MalfunctionNov 26, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING AN ACL, THE BEVEL 45 ICW FRONT SECTION WAS BURNED, AND IT COULD NOT BE USED. THE DEVICE OVER-HEATED, AND BECAME HOT TO TOUCH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY, OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912850 ↗
• MalfunctionNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING FORAMEN INTERVERTEBRAL ENDOSCOPIC SURGERY, A BEVEL 45 ICW WAND HAD ABLATION AND COAGULATION FAILURES WHEN USE. A BACKUP WAS AVAILABLE AND A DELAY GREATER THAN 30 MINUTES WAS REPORTED WITH NO OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10786215 ↗
• MalfunctionMay 14, 2018Sparking

  IT WAS REPORTED THAT DURING THE SURGERY A SPARK JUMPED FROM THE TIP OF THE DEVICE, AT THE SAME TIME THE SCREEN OF THE ANESTHESIA MONITOR TURNED OFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7512998 ↗

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