CODMAN 24-5404Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20886704004131), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Component Missing; Component Missing

  A FACILITY REPORTED A SURGICAL PATTIE (ID 245404) WAS NOTED TO BE MISSING THE BLUE STRIP AND WAS UNABLE TO BE FOUND. AFTER GETTING ALL 10 PATTIES OFF THE FIELD, ONE PATTIE WAS NOTED TO BE MISSING THE BLUE STRIP AND WAS UNABLE TO BE FOUND. THE EVENT DID NOT LEAD TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097969 ↗

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-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
• 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-0093-2011 · Jul 16, 2010 · Terminated
  Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396