LEEP Ball Electrode B0512Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937010916), received between Feb 2, 2024 and Feb 2, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K905747); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE BALL ELECTRODES WERE NOT CAUTERIZING. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. 1216677-2024-00001 B0512 BALL ELECTRODES 2024-01-0000379.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631012 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K905747. One submission often covers many models, so check the product and lot details in each record.

• Z-0484-2015 · Oct 27, 2014 · Terminated
  CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related o