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CODMAN® 245407Recalls & reported problems

Integra Lifesciences Production Corporation · CODMAN® Bulk Surgical Patties X-Ray Detectable 1" x 1" (2.54cm x 2.54cm) · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780513407), received between Aug 2, 2024 and Apr 24, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Component Missing1
  • Detachment of Device or Device Component1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    A FACILITY REPORTED THE RADIOPAQUE STRING OF A SURGICAL PATTIE (ID 245407) WAS DETACHED FROM THE PATTIE. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21899500 ↗
  • InjuryAug 2, 2024Component Missing; Component Missing

    N/A.

    Patient problems: Insufficient Information

    MAUDE report 19893440 ↗

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

All Neurosurgical paddie devices →

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