CODMAN 80-1407Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20886704036545), received between Jul 17, 2020 and Mar 1, 2022 — classified as 2 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-0245-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2022Contamination; Contamination

  A FACILITY REPORTED YELLOW STAINS IN SURGICAL PATTIES ((B)(4)) WHEN THE SCRUB NURSE OPENED THE PACKAGE DURING THE SURGERY PREPARATION. THE PRODUCT WAS STORED IN A 24 HOURS TEMPERATURE CONTROLLED GOODS LOCATED ON SHELF IN A MEDICAL CONSUMABLE STORE IN HOSPITAL. NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13636060 ↗
• MalfunctionJul 17, 2020Material Integrity Problem; Material Integrity Problem

  UPON COMPLETION OF THE SURGERY AND WHILE IN THE OPERATING ROOM, THE COTTONOID SPONGE 9 INCH STRING BROKE OFF WHILE ATTEMPTING TO REMOVE IT FROM THE LEFT NASAL CAVITY. THE MISSING SURGICAL ITEM (MSI) RADIOLOGIC FILM VERIFIED RETAINED RADIOPAQUE FOREIGN BODY IN POSTERIOR LEFT NASAL CAVITY. THE SURGEON WAS ABLE TO REMOVE IT SUCCESSFULLY AND THE PATIENT HAD A STABLE RECOVERY. THE SURGERY PERFORMED WAS A NASAL SEPTOPLASTY WITH BILATERAL INFERIOR NASAL TURBINATE SUBMUCOUS RESECTION AND LATERAL OUTFRACTURE WITH BILATERAL MAXILLARY ETHMOID, FRONTAL AND SPHENOID SINUS SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10292990 ↗

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