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CODMAN 80-1399Recalls & reported problems

Cerenovus, Inc. · CODMAN Surgical Patties 1/4 Inch x 1/4 Inch (0.64cm x 0.64cm) · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20886704036477), received between May 17, 2023 and May 17, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Separation Problem” (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-0238-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Separation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 17, 2023Separation Problem; Separation Problem

    A FACILITY REPORTED A SURGICAL PATTY (ID 801399) WAS PLACED IN SITU ON THE BRAIN. HOWEVER, WHEN SURGEON WENT TO REMOVE PATTY BY PULLING THE STRING, THE STRING CAME AWAY AND LEFT THE PATTY IN SITU. THE PATTY WAS REMOVED FROM BRAIN AFTER IT WAS NOTICED TO BE STILL IN SITU AFTER PULLING THE STRING OFF. WHEN THE PATTY WAS PLACED ON THE BRAIN IT WAS NOT MOISTENED AS IT WAS ALREADY IN SITU TO ABSORB BLOOD. THE PATTIES WERE MOISTENED WITH RINGERS SOLUTION WITHIN 5 MINUTES PRIOR TO USE. IT WAS NOT ALTERED OR CUT FROM THE ORIGINAL SIZE PRIOR TO USE, AND NO DELAY OF THE PROCEDURE WAS REPORTED. SURGICAL PROCEDURE: RETRO SIGMOID REPAIR OF RIGHT MASTOID ENCEPHALOCELE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16946524 ↗

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

Other NEUROSURGICAL PADDIE devices

All NEUROSURGICAL PADDIE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.