CODMAN® 801404Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10381780515005), received between Sep 22, 2021 and Aug 27, 2024 — classified as 4 malfunctions.

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

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-0243-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2024Material Separation; Material Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078374 ↗
• MalfunctionOct 4, 2023Extra Components; Extra Components

  N/A

  Patient problems: Insufficient Information

  MAUDE report 17868218 ↗
• MalfunctionOct 19, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A FACILITY REPORTED THERE WERE 11 SURGICAL PATTIES IN THE PACKET INSTEAD OF 10. NO PATIENT INJURY REPORTED. IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662317 ↗
• MalfunctionSep 22, 2021Contamination; Contamination

  A DISTRIBUTOR REPORTED THE SURGICAL PATTIE WAS SEALED WITH A HAIR INSIDE. ISSUE WAS DETECTED DURING INSPECTION AT THE DISTRIBUTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512493 ↗

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-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