CODMAN® 245412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780513445), received between Feb 2, 2022 and Feb 13, 2024 — classified as 2 malfunctions.

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

3 other recalls cover devices cleared under the same FDA submission (K880402); 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.

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.

• MalfunctionFeb 13, 2024Contamination; Contamination

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2024-00023; 3014334038-2024-00024; 3014334038-2024-00025. A FACILITY REPORTED A HAIR WAS FOUND IN A SURGICAL PATTY (ID 245404) BEFORE A PROCEDURE, AFTER THE SET-UP PROCESS WAS COMPLETE AND CONTAMINATED THE ENTIRE SET-UP. THERE WAS A DELAY OF APPROXIMATELY 60 MINUTES. THE ENTIRE SET UP WAS DISCARDED, THE AREA WAS CLEANED, AND A NEW PACK WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695419 ↗
• MalfunctionFeb 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A FACILITY REPORTED A FOREIGN BODY WAS FOUND IN A SURGICAL PATTIE (ID 245412) BEFORE A PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423283 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K880402. One submission often covers many models, so check the product and lot details in each record.

• Z-0093-2011 · Jul 16, 2010 · Terminated
  Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396
• Z-0094-2011 · Jul 16, 2010 · Terminated
  Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
• Z-0095-2011 · Jul 16, 2010 · Terminated
  Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403