CODMAN® 801400Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10381780514961), received between Apr 1, 2021 and Oct 4, 2023 — classified as 9 malfunctions.

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

2 FDA recall records name this device's identifier, 2 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-0239-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Dec 2, 2022Open, Classified

   Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

   Z-0909-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2023Contamination; Contamination

  A FACILITY REPORTED A HAIR WAS FOUND INSIDE STERILE PACKAGING OF A SURGICAL PATTY ID (B)(6). THE ISSUE OCCURRED PRE-SURGERY, NO PATIENT CONTACT/INJURY AND THE EVENT DID NOT LED TO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PRODUCT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17868756 ↗
• MalfunctionAug 8, 2023Material Separation; Material Separation

  N/A

  Patient problems: Insufficient Information

  MAUDE report 17483732 ↗
• MalfunctionApr 18, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  A FACILITY REPORTED A POSSIBLE OIL STAIN OR SEALANT DAMAGE ON A SURGICAL PATTIE PACKAGE SEAL (ID (B)(4)). ISSUE DETECTED BY THE DISTRIBUTOR: "ALL THE SEALS HAVE THIS OIL LIKE SUBSTANCE, ONLY ON THE SEALS. WHEN LIFTING UP IN THE LIGHT, IT HAS A SEE-THROUGH EFFECT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766030 ↗
• MalfunctionApr 5, 2023Contamination; Contamination

  A FACILITY REPORTED A SMALL ORANGE FOREIGN OBJECT WITHIN THE PACKAGING OF A SURGICAL PATTIE (ID 801400). THE ISSUE WAS DETECTED DURING PRE-SURGERY AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684696 ↗
• MalfunctionDec 20, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  A FACILITY REPORTED THE SURGICAL PATTIES (ID 801400) DID NOT SHOW UP ON X-RAY. THEY EVEN TESTED OUTSIDE OF BODY ON THE FIELD. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019237 ↗
• MalfunctionFeb 8, 2022Material Separation; Material Separation

  A FACILITY REPORTED THE WHITE CLOTH ATTACHED TO GREEN STRING OF THE SURGICAL PATTIE IS STAYING IN THE PATIENT. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13484267 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  A FACILITY REPORTED SURGICAL PATTIE PARTLY ATTACHED TO THE STRING OR NOT ATTACHED AT ALL. ISSUE DETECTED PRIOR TO SURGERY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342564 ↗
• MalfunctionApr 1, 2021Material Integrity Problem; Material Integrity Problem

  1 OF 2 REPORTS. SAME FAILURE - DIFFERENT PATIENTS OTHER MFG REPORT NUMBER: 3014334038-2021-00064. A FACILITY REPORTED A FUNCTIONAL ISSUE WITH SURGICAL PATTIES. THE SURGICAL PATTIES WERE USED IN TWO SURGICAL CASES. WHEN THE PATTIES WERE USED IN THE LARYNX DRY OR SOAKED WITH ADRENALINE, THE PATTIES REPORTEDLY DISINTEGRATED, WHEREIN SMALL PARTICLE OF FIBERS WERE SCATTERED IN THE THROAT. THE SURGEON PICKED OFF EVERY SINGLE FIBER ONE BY ONE. THE EVENT LED TO AN INCREASE IN SURGICAL TIME. THERE WERE NO LONG-TERM CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606587 ↗
• MalfunctionApr 1, 2021Material Integrity Problem; Material Integrity Problem

  2 OF 2 REPORTS. SAME FAILURE - DIFFERENT PATIENTS OTHER MFG REPORT NUMBER: 3014334038-2021-00063. A FACILITY REPORTED A FUNCTIONAL ISSUE WITH SURGICAL PATTIES. THE SURGICAL PATTIES WERE USED IN TWO SURGICAL CASES. WHEN THE PATTIES WERE USED IN THE LARYNX DRY OR SOAKED WITH ADRENALINE, THE PATTIES REPORTEDLY DISINTEGRATED, WHEREIN SMALL PARTICLE OF FIBERS WERE SCATTERED IN THE THROAT. THE SURGEON PICKED OFF EVERY SINGLE FIBER ONE BY ONE. THE EVENT LED TO AN INCREASE IN SURGICAL TIME. THERE WERE NO LONG-TERM CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11606585 ↗

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