CODMAN® ISOCOOL® AHT® 8135050SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780517313), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionApr 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A FACILITY REPORTED A NURSE NOTICED AN EYELASH INSIDE THE STERILE PACKET THAT WAS STILL SEALED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14174794 ↗

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