CODMAN® 801451Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780515074), received between Jan 26, 2022 and Feb 13, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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-0250-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Flaked; Flaked

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18698226 ↗
• MalfunctionJun 1, 2023Component Missing; Component Missing

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042736 ↗
• MalfunctionMay 19, 2022Component Missing; Component Missing

  A FACILITY REPORTED A SURGICAL STRIP PACKAGE (ID (B)(4)) HAS 9 SPONGES INSTEAD OF 10. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434947 ↗
• MalfunctionApr 20, 2022Flaked; Flaked

  A FACILITY REPORTED A SURGICAL STRIP (ID 801451) DISCONNECTED FROM THE REST DURING A LAPAROSCOPIC EXCISION OF ENDOMETRIOSIS PROCEDURE. THE SURGICAL STRIP WAS USED AND REMOVED FROM THE PATIENT AND WHEN STAFF WAS IRRIGATING THE AREA A NURSE NOTED A PIECE FLOATING IN PATIENT'S ABDOMEN. THE PRODUCT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE AND WAS NOT SOAKED NOR IRRIGATED PRIOR TO USE. NO PATIENT INJURY REPORTED AND IT IS UNKNOWN IF THE EVENT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162018 ↗
• MalfunctionJan 26, 2022Material Frayed; Material Frayed

  THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00008. A FACILITY REPORTED SURGICAL STRIP ((B)(4)) FRAYED WHILE BEING USED IN SURGERY. NO PATIENT INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359358 ↗

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