CODMAN® 801407Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10381780515029), received between Nov 2, 2022 and Mar 5, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 reports).

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

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.

Recalls naming this device

1. Sep 20, 2024Open, Classified

   Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in finished goods

   Z-0245-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2024Material Separation; Material Separation

  A FACILITY REPORTED A PATIENT UNDERWENT BRAIN TUMOR RESECTION SURGERY UNDER GENERAL ANESTHESIA ON (B)(6) 2024. DURING THE OPERATION, 50 PIECES OF THREADED COTTON PADS WERE USED. THE ATTENDING PHYSICIAN REMOVED THE THREADED COTTON PADS FROM THE SURGICAL SITE AND HANDED THEM TO THE HAND BRUSHING NURSE. THE NURSE IMMEDIATELY COUNTED THEM IT WAS FOUND THAT A PIECE OF COTTON WAS BROKEN FROM THE THREAD, LEAVING ONLY THE THREAD BUT NO COTTON PIECE. THE NURSE IMMEDIATELY INFORMED THE SURGEON THAT THE COTTON PIECE HAD NOT BEEN RETURNED AND ONLY THE THREAD WAS LEFT. THEY IMMEDIATELY SEARCHED FOR CLOTH, TRASH CANS AND THE FLOOR NEAR THE SURGICAL SITE, BUT NONE WAS FOUND. IN ACTUAL COUNTING, THERE WERE ONLY 49 THREADED COTTON PADS. THE SUPERVISOR WAS NOTIFIED IMMEDIATELY AND THE RADIOLOGY DEPARTMENT WAS CONTACTED FOR A PORTABLE INSPECTION DURING THE OPERATION. THE IMAGE SHOWED THAT THERE WERE NO COTTON PADS AT THE SURGICAL SITE. AFTER EVALUATION BY THE ATTENDING PHYSICIAN, THE WOUND WAS SUTURED AND THE DRAPE WAS REMOVED AFTER THE OPERATION. THE PATTIES WERE IRRIGATED DURING USE. IT WAS SOAKED FOR 5 MINUTES THEN SQUEEZE DRY. IT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE PRIOR TO USE. A PHYSI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838537 ↗
• MalfunctionDec 8, 2023Contamination; Contamination

  A FACILITY REPORTED "DIRT" WAS FOUND IN A SURGICAL PATTY (ID 801407) WHEN IT WAS OPENED DURING A PROCEDURE PRIOR TO PATIENT USE. THEREFORE, ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS LESS THAN 30 MINUTES OF SURGICAL DELAY IN THE PROCEDURE, AND NO ADVERSE CONSEQUENCES WAS OBSERVED. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN HOW AND WHERE THE PRODUCT WAS STORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18291691 ↗
• MalfunctionAug 1, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 17435194 ↗
• MalfunctionJul 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305528 ↗
• MalfunctionMay 9, 2023Contamination; Contamination

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 16894498 ↗
• MalfunctionNov 2, 2022Contamination; Contamination

  A PHYSICIAN REPORTED "DIRT" WAS FOUND ON A SURGICAL PATTIE (ID: 801407) WHEN IT WAS OPENED DURING THE PROCEDURE PRIOR TO PATIENT USE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716811 ↗

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