CODMAN® 261230Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780513629), received between Aug 2, 2022 and Jun 9, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 11, 2025Open, Classified

   Inadequate weld that can potentially cause the product to disassemble.

   Z-1717-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR (ID: 261230) FAILED TO DISENGAGE CAUSING A DURAL INJURY REQUIRING TO BE REPAIRED WITH COAGULATION OF THE VESSEL ON THE SURFACE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.

  Patient problems: Brain Injury

  MAUDE report 17100888 ↗
• InjuryDec 21, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  N/A.

  Patient problems: Brain Injury

  MAUDE report 16022588 ↗
• InjuryAug 2, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR DID NOT DISENGAGE CAUSING A TEAR IN THE DURA MATTER. SUTURE WAS NECESSARY TO STOP THE BLEEDING OF THE SUPERIOR SAGITTAL SINUS. THE PERFORATOR WAS USED IN A SURGERY FOR MENINGIOMA.

  Patient problems: Brain Injury

  MAUDE report 15148291 ↗