CODMAN® ISOCOOL® 8010010HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780514565), received between Aug 24, 2022 and Aug 24, 2022 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K083895); 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.

• MalfunctionAug 24, 2022Crack; Melted; Crack; Melted

  A FACILITY REPORTED AN ISOCOOL BIPOLAR FORCEPS HANDLE FLAT STYLE (ID 8010010H) WAS STERILIZED IN AN AUTOCLAVE AND PART OF THE HANDLE MELTED, AND CRACKS OCCURRED AT THE CORD CONNECTION BEFORE THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083895. One submission often covers many models, so check the product and lot details in each record.

• Z-2206-2019 · Jul 19, 2019 · Terminated
  Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and