CODMAN® 9190001GFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780521730), received between Apr 11, 2024 and Jul 31, 2025 — classified as 2 malfunctions.

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

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Failure to Power Up; Failure to Power Up

  A PHYSICIAN REPORTED A DISPOSABLE CODMAN CORD AND TUBING (ID 9190001GF) HAD INTERMITTENTLY UNSTABLE OUTPUT OR WOULD NOT TURN ON WHEN CONNECTING TO THE MAIN DEVICE. THE MAIN DEVICE AND BIPOLAR FORCEPS WERE REPLACED ALTERNATELY. DESPITE THESE EFFORTS, THE ISSUE PERSISTED, AND THE PRODUCT WAS REPLACED WITHOUT IMPROVEMENT. UPON CONNECTING A THIRD CORD, THE DEVICE FUNCTIONED PROPERLY. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE OBSERVED. HOWEVER, THE INCIDENT RESULTED IN A SURGICAL DELAY OF MORE THAN 30 MINUTES. BASED ON ADDITIONAL INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE "MAIN DEVICE" AND "BIPOLAR FORCEPS" INVOLVED WERE INTEGRA PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22677263 ↗
• MalfunctionApr 11, 2024Contamination; Contamination

  A FACILITY REPORTED THAT UPON OPENING THE PRODUCT BEFORE SURGERY, A FOREIGN MATTER (HAIR) WAS FOUND IN THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SURGICAL DELAY WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19091176 ↗