CODMAN® 245406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780513391), received between Jun 29, 2022 and Aug 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 reports).

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

• MalfunctionAug 21, 2024Component Missing; Component Missing

  MEDWATCH #: (B)(4). A FACILITY REPORTED AN INCORRECT COUNT OF SURGICAL PATTY (ID 245406) DURING INITIAL COUNT. THERE WERE ONLY 9 COTTONOIDS IN THE PACK. IT WAS COUNTED TWICE BUT ONLY 9 WERE COUNTED. THE PRODUCTS WERE TAKEN OFF THE FIELD AND A NEW COTTONOID WAS OPENED. NO PATIENT INJURY REPORTED, AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015376 ↗
• MalfunctionJul 21, 2023Component Missing; Component Missing

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370593 ↗
• MalfunctionJun 29, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  A FACILITY REPORTED A SURGICAL PATTIE (ID 245496) WAS COVERED IN A BROWN RESIDUE. ALMOST AS IF COFFEE HAD SPLATTERED ON IT AS DESCRIBED BY THE REPORTER. THE PATTIE WAS STORED ON ITS ORIGINAL PACKAGED AND WAS STORED ON A STOCKROOM SHELF. THE FACILITY HAVE THESE STORED FOR A COUPLE OF WEEKS. NO DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852817 ↗

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-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