CODMAN® 245404Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10381780513377), received between Feb 8, 2022 and Nov 15, 2024 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 reports).

26 other recalls cover devices cleared under the same FDA submission (K193346, 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Material Separation; Material Separation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694708 ↗
• MalfunctionFeb 13, 2024Contamination; Contamination

  THIS IS 1 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2024-00024 3014334038-2024-00025 3014334038-2024-00026 A FACILITY REPORTED A HAIR WAS FOUND IN A SURGICAL PATTY (ID (B)(6)) BEFORE A PROCEDURE, AFTER THE SET-UP PROCESS WAS COMPLETE AND CONTAMINATED THE ENTIRE SET-UP. THERE WAS A DELAY OF APPROXIMATELY 60 MINUTES. THE ENTIRE SET UP WAS DISCARDED, THE AREA WAS CLEANED, AND A NEW PACK WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695423 ↗
• MalfunctionFeb 13, 2024Contamination; Contamination

  THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2024-00023 3014334038-2024-00025 3014334038-2024-00026 A FACILITY REPORTED A HAIR WAS FOUND IN A SURGICAL PATTY (ID (B)(6)) BEFORE A PROCEDURE, AFTER THE SET-UP PROCESS WAS COMPLETE AND CONTAMINATED THE ENTIRE SET-UP. THERE WAS A DELAY OF APPROXIMATELY 60 MINUTES. THE ENTIRE SET UP WAS DISCARDED, THE AREA WAS CLEANED, AND A NEW PACK WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695420 ↗
• MalfunctionMar 9, 2023Material Integrity Problem; Material Integrity Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16516551 ↗
• MalfunctionFeb 28, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  SMALL BLUE STRIP ON CODMAN 0.5X0.5 NEURO PATTIES THAT COME INSIDE THE CRANI PACK KIT. AFTER GETTING ALL 10 PATTIES OFF THE FIELD, ONE PATTY WAS NOTED TO BE MISSING THE BLUE STRIP AND WAS UNABLE TO BE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452263 ↗
• MalfunctionFeb 20, 2023Separation Problem; Separation Problem

  A FACILITY REPORTED THE BLUE STRIP CAME OFF A SURGICAL PATTIE (ID 245404). THE EVENT HAPPENED DURING PROCEDURE, NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401637 ↗
• MalfunctionJan 24, 2023Material Separation; Material Separation

  A FACILITY REPORTED A SURGICAL PATTIE'S (245404) X-RAY DETECTABLE TAB IS EASILY REMOVED. ISSUE WAS DISCOVERED PRIOR TO USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235022 ↗
• InjuryJan 24, 2023Material Separation; Material Separation

  A PHYSICIAN REPORTED A PATTIE'S (ID 245404) X-RAY DETECTABLE TAB CAME OFF OF THE STRING. "CLINICAL TEAM CLOSED THE SURGICAL SITE BUT THEN REALIZED THE COUNT WAS OFF. SENT THE PATIENT FOR X-RAY AND CONFIRMED THE ITEM WAS LEFT INSIDE OF THE PATIENT. CLINICAL TEAM TOOK THE PATIENT BACK INTO THE OR, OPENED THE SURGICAL SITE BUT COULDN'T LOCATE THE ITEM." ADDITIONAL INFORMATION RECEIVED: "DURING THE PROCEDURE, ONE OF THE SMALL BLUE STRIPS ON THE CODMAN 0.5X0.5 NEURO PATTIES FROM THE CRANI PACK KIT WAS NOTED TO BE MISSING. AFTER RECEIVING ALL 10 OF THE PATTIES FROM THE PACK OFF THE FIELD, IT WAS NOTED THAT THE BLUE STRIPS WERE FALLING OFF AND EASY TO REMOVE. ONE OF THOSE 10 PATTIES, THE GREEN STRING THAT IS ATTACHED TO IT CAME COMPLETELY OFF THE PATTY. ONLY 1 OF THE 10 PATTIES WAS MISSING A SMALL BLUE STRIP AND ALL 10 PATTIES HAD ALL THEIR STRINGS ACCOUNTED FOR. THE COUNT WAS DOCUMENTED AS CORRECT AS ALL THE PATTIES WERE ACCOUNTED FOR. THE PHYSICIAN WAS AWARE OF THE ISSUE WITH THE PATTIES AND DECIDED TO GET A X-RAY TO CONFIRM THE BLUE STRIP WAS NOT LEFT IN THE INCISION. THEY DID ATTEMPT TO FIND THE SMALL BLUE STRIP AND SEARCHED THE INCISION, BUT WERE UNABLE TO FIND IT. BOTH PHYSICIANS AG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234141 ↗
• MalfunctionMar 8, 2022Material Fragmentation; Material Fragmentation

  A FACILITY REPORTED THE BLUE STRIP OF THE SURGICAL PATTIE CAME OFF THE COTTONOID DURING PROCEDURE AND THEY WERE UNABLE TO FIND THE PRODUCT. NO SURGICAL DELAY REPORTED. AN X-RAY WAS TAKEN TO ASSURE NO PART LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694823 ↗
• MalfunctionFeb 8, 2022Material Separation; Material Separation

  IT WAS REPORTED THE BLUE STRIP WAS SEPARATED FROM THE NEURO SPONGE INSIDE THE PATIENT. THE STAFF SAW IT BEFORE THEY CLOSED UP AND HAD TO IRRIGATE THE WOUND AND SCAN FOR THE SPONGES AND ANY REMAINING PIECES. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13484207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193346, K880402. One submission often covers many models, so check the product and lot details in each record.

• Z-0239-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of
• 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-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-0254-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the cen
• 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-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-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-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-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-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-0247-2025 · Sep 20, 2024 · Open, Classified
  SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the
• 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-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-0248-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the c
• Z-0255-2025 · Sep 20, 2024 · Open, Classified
  SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the cen

…and 11 more.