CODMAN® 801457Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780515135), received between Apr 19, 2022 and Apr 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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-0256-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionApr 19, 2022Peeled/Delaminated; Peeled/Delaminated

  A FACILITY REPORTED DELAMINATION OF THE SURGICAL STRIPS ((B)(4)) DURING PROCEDURE. THE NURSE MANAGED TO RETRIEVE ALL THE PIECE THAT CAME OFF. HOWEVER, THIS CAUSED AN IMPACT IN THE MANAGEMENT OF THE PATIENT BECAUSE IT WAS IMPOSSIBLE TO USE THIN PIECES (THEY SWELLED UP TOO MUCH ONCE PUT IN THE SALINE AND THEY SPLIT: DELAMINATE). THE EVENT LED TO 15 MINUTES SURGICAL DELAY, WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141531 ↗

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-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
• Z-0093-2011 · Jul 16, 2010 · Terminated
  Codman 5/16" Round Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1396