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CODMAN® 801401Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® Surgical Patties 3/4" x 3/4" (1.91cm x 1.91cm) · 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 10381780514978), received between Mar 14, 2023 and Mar 14, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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-0240-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Defective Device1
  • Extra Components1

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.

  • MalfunctionMar 14, 2023Defective Device; Extra Components; Defective Device; Extra Components

    A FACILITY REPORTED THAT DURING SURGERY (REMOVAL OF A RIGHT NASAL CAVITY LESION), MEDICAL STAFF COUNT 11 PATTIES INSTEAD OF 10 AND THE 11TH ONE HAS NO STRING. NO PATIENT CONSEQUENCES REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16540932 ↗

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-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

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.