CODMAN® 826607Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780520337), received between Jun 9, 2023 and Sep 13, 2024 — classified as 2 malfunctions.

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

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

2 other recalls cover devices cleared under the same FDA submission (K914479); 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.

Recalls naming this device

1. Apr 11, 2023Open, Classified

   Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.

   Z-1614-2023 · Root cause: Under Investigation by firm · 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.

• MalfunctionSep 13, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A FACILITY REPORTED THEY FOUND HAIRS IN STERILE PACKAGING OF A CRANIAL HAND DRILL (ID 826607). ISSUE DETECTED BEFORE PRODUCT USE AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212892 ↗
• MalfunctionJun 9, 2023Corroded; Corroded

  A FACILITY REPORTED RUST ON THE BASE OF A HAND DRILL (ID 826607) DURING A STOCK CHECK OF INVENTORY. THE HAND DRILLS WERE NOT USED IN A KIT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098231 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K914479. One submission often covers many models, so check the product and lot details in each record.

• Z-0706-2012 · Oct 25, 2011 · Terminated
  Codman Cranial Access Kit with Xylocaine Product Code: 82-6612 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and the drug (Xy
• Z-0707-2012 · Oct 25, 2011 · Terminated
  Codman Cranial Access Kit - complete with Xylocaine Product Code: 82-6614 Product Usage: The Codman Cranial Access and ICP Kits are convenience kits which provide devices and th