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CODMAN® 801399Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® Surgical Patties 1/4" x 1/4" (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 10381780514954), received between Apr 20, 2022 and Apr 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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

  • Material Disintegration1

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.

  • MalfunctionApr 20, 2022Material Disintegration; Material Disintegration

    A NURSE REPORTED A SURGICAL PATTY (ID (B)(4)) WAS PLACED IN A PATIENT¿S THROAT AND IT BEGAN TO DISINTEGRATE CAUSING FIBERS TO LOOSEN AND STAY IN THE THROAT. THE PRODUCT AND FIBERS WERE ALL REMOVED FROM PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14160283 ↗

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

Other Neurosurgical paddie devices

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