Tissue-Tek® 4223Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00615233078391), received between Apr 3, 2024 and Apr 23, 2024 — classified as 2 malfunctions.

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

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.

• MalfunctionApr 23, 2024Crack; Material Integrity Problem; No Apparent Adverse Event; Crack; Material Integrity Problem; No Apparent Adverse Event

  SAKURA FINETEK USA WAS NOTIFIED BY FDA ON 3-APR-2024 ABOUT THE MEDICAL DEVICE REPORT SUBMITTED VIA MEDWATCH PROGRAM. THE EMAIL NOTIFICATION FROM FDA INCLUDED NOTIFICATION LETTER AND THE SUBMITTED MEDICAL DEVICE REPORT FOR SAKURA FINETEK USA'S AWARENESS. THE MEDICAL DEVICE REPORT (FORM 3500A) WAS SUBMITTED BY THE CUSTOMER'S REPRESENTATIVE, (B)(6) OF (B)(6) CLINIC LOCATED IN (B)(6) IN B)(6) 2023 FOR THE EVENT THAT TOOK PLACE IN B)(6) 2023. IN THE REPORT SUBMITTED TO THE FDA, CUSTOMER HAS DESCRIBED THAT THE MESH BIOPSY BAGS ARE USED TO HOLD TISSUES WHEN GROSSING TO KEEP THEM SAFE, BEFORE BEING INSERTED INTO CASSETTES. THE MESH BAGS THAT WERE THEN THEIR CURRENT LOT WERE TEARING APART AT THE EDGES WHEN OPENING THEM TO PUT TISSUES IN AND NOT HOLDING THEIR SHAPE. THE CUSTOMER MENTIONED THAT THIS DEVICE DEFECT GIVES TISSUES THE POTENTIAL TO BE LOST OUT THE SIDE OF THESE BAGS. THEY ALSO HAVE MENTIONED THAT, THERE HAD BEEN AN INCREASE IN NUMBER OF BAGS TEARING APART AT THE EDGES CAUSING THE GROSSING TECH TO THROW THEM AWAY OR IF THEY ARE NOT CAUGHT AT THE TIME A POTENTIAL FOR LOSS OF IRRETRIEVABLE TISSUES. THEY HAVE CATEGORIZED THE USER PROBLEM AS DEVICE FAILED (E.G. BROKE, COULDN'T GET IT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169504 ↗
• MalfunctionApr 3, 2024

  MESH BIOPSY BAGS ARE USED TO HOLD TISSUES WHEN GROSSING TO KEEP THEM SAFE, BEFORE BEING INSERTED INTO CASSETTES. THE CURRENT MESH BAGS ARE TEARING APART AT THE EDGES WHEN OPENING THEM TO PUT TISSUES IN AND NOT HOLDING THEIR SHAPE. THIS GIVES TISSUES THE POTENTIAL TO BE LOST OUT THE SIDE OF THESE BAGS. THERE HAS BEEN AN INCREASED NUMBER OF BAGS TEARING APART AT THE EDGES CAUSING THE GROSSING TECH TO THROW THEM AWAY OR IF THEY ARE NOT CAUGHT AT THE TIME A POTENTIAL FOR LOSS OF IRRETRIEVABLE TISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031495 ↗