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CODMAN 80-1408Recalls & reported problems

Cerenovus, Inc. · CODMAN Surgical Patties 1 Inch x 3 Inches (2.54cm x 7.62cm) · 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 20886704036552), received between Aug 2, 2018 and Aug 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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-0246-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Delivered as Unsterile Product1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionAug 2, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

    AS REPORTED BY THE AFFILIATE, THE STERILE PACKAGING OF SURGICAL PATTIES HAD BEEN BREACHED. ANOTHER PACK WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF DELAYS OR PATIENT HARM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7744066 ↗

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

All NEUROSURGICAL PADDIE devices →

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