CODMAN ISOCOOL AHT 8135200SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704040149), received between Aug 1, 2018 and Aug 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. 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.

• MalfunctionAug 1, 2018Material Integrity Problem; Material Integrity Problem

  AS REPORTED BY THE AFFILLIATE, ISOCOOL FORCEPS TIPS MALFUNCTIONED. AFTER CHANGING THE TIPS, FORCEPS AGAIN COAGULATED. ONE OF THE TIPS WAS BROKEN. THERE WERE NO REPORTS OF DELAY OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738464 ↗

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