CODMAN® 245431Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780513469), received between Apr 18, 2023 and Sep 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

23 other recalls cover devices cleared under the same FDA submission (K193346); 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 6, 2023Extra Components; Extra Components

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690420 ↗
• MalfunctionApr 18, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  A FACILITY REPORTED "DIRT" ON A PATTIE STRIP (ID 245431). NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED AFTER SEVERAL ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765810 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193346. One submission often covers many models, so check the product and lot details in each record.

• Z-0235-2025 · Sep 20, 2024 · Open, Classified
  MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID Material with x-ray detectable markers. All patties ha
• Z-0240-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of
• Z-0237-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of t
• Z-0252-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• Z-0251-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the c
• Z-0250-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the c
• Z-0238-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of
• Z-0249-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the c
• Z-0236-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues
• Z-0246-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• Z-0241-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of t
• Z-0256-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• Z-0242-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• Z-0253-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• Z-0245-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of t

…and 8 more.