CODMAN® 261223Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780513612), received between Mar 23, 2022 and Jun 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 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. Sep 26, 2025Open, Classified

   Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.

   Z-0373-2026 · Root cause: Process change control · FDA record ↗

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.

• MalfunctionJun 28, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR (ID 261223) DID NOT DISENGAGE, IT WAS HOT AND THE METALLIC PART GOT STUCK IN THE BONE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY, NO SURGICAL DELAY. TEST WAS DONE BEFORE USE AND IT WAS WORKING AS EXPECTED. THE MOTOR USED IS MOTOR HOSE AESCULAP B BRAUN AND THE SPEED WAS 60000 TURN / MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843331 ↗
• MalfunctionMar 23, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  A FACILITY REPORTED A PERFORATOR (ID 261223) DID NOT DISENGAGE DURING MAKING THE FIRST HOLE. WHEN ATTEMPTED TO RETRIEVE IT FROM PATIENT'S HEAD, IT BROKE IN TWO PARTS. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT INJURY AND NO SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13862194 ↗