CODMAN 26-1222Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704005117), received between May 17, 2022 and Oct 4, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 reports).

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

• MalfunctionOct 4, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 20369178 ↗
• InjuryMay 17, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR (ID 261222 ) FAILED TO DISENGAGE; DURA MATER WAS TORN, THERE WAS POSSIBLE DAMAGE TO CORTEX AND BLEEDING WAS HARD TO STOP. A CEREBRAL CONTUSION WAS VISIBLE ON POSTOPERATIVE SCAN. PATIENT WAS ASYMPTOMATIC.

  Patient problems: Brain Injury; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14414853 ↗