Tissue-Tek VIP® 6 6040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04946433600539), received between May 29, 2025 and Jun 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryJun 11, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ON APRIL 7, 2025, (B)(6) NOTIFIED SAKURA FINETEK USA TECHNICAL SERVICES (TS) OF AN INCIDENT THAT OCCURRED ON (B)(6) 2025, INVOLVING THE TISSUE-TEK VIP 6 AI VACUUM INFILTRATION PROCESSOR (115 VAC, 50/60 HZ, 12 A). ON THE DAY OF THE INCIDENT, THE UNIT PROCESSED 140 TISSUE SAMPLES- A MIX OF FATTY AND LARGE AUTOPSY TISSUES- WHICH APPEARED TO BE EITHER OVER-PROCESSED OR UNDER-PROCESSED. (B)(6) REPORTED THAT, IN SOME CASES, THE NUCLEI WERE COMPLETELY OBLITERATED, GIVING THE TISSUE THE APPEARANCE OF AUTOLYZED OR "COOKED" AUTOPSY TISSUE. ALL CASSETTES FROM THAT PROCESSING RUN WERE AFFECTED TO VARYING DEGREES, THOUGH ONLY FOUR CASES WERE DEEMED UNDIAGNOSABLE: THREE BREAST TISSUE CASES AND ONE COLON CASE WITH LYMPH NODES. ACCORDING TO (B)(6), THESE FOUR CASES WERE SIGNED OUT AS UNDIAGNOSABLE DUE TO PROCESSING ERRORS AND ARTIFACTS THAT RENDERED THE TISSUE SLIDES UNREADABLE. SAKURA FINETEK USA RECEIVED FURTHER DETAILS REGARDING THE INDIVIDUAL CASES AT A LATER DATE DUE TO HIPAA RESTRICTIONS. THE REPORTED CASES WERE SUMMARIZED AS FOLLOWS: CASE 1: COLON CANCER- STAGING COULD NOT BE DETERMINED. CASE 2: MASTECTOMY WITH A PRIOR DIAGNOSIS OF DCIS- UNABLE TO CONFIRM THE PRESENCE OF INVASIVE CANCER. CA

  Patient problems: Insufficient Information

  MAUDE report 22187929 ↗
• InjuryMay 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SAKURA FINETEK USA WAS NOTIFIED BY FDA ON 30-APR-2025 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 AN ANONYMOUS CUSTOMER FOR THE EVENT THAT TOOK PLACE IN 19-MAR-2025. IN THE REPORT SUBMITTED TO THE FDA, CUSTOMER HAS DESCRIBED THAT A TISSUE PROCESSING ISSUE WAS IDENTIFIED, AFFECTING A SUBSET OF PATHOLOGY CASES LEADING TO TISSUE PROCESSING/FIXATION ISSUES. SEVERAL TISSUE SAMPLES WERE AFFECTED; HOWEVER, THREE CASES REMAINED SUBOPTIMAL FOR READING WHICH AFFECTED PATIENT CARE. THESE CASES EITHER REQUIRE A CHANGE IN TREATMENT PLAN OR A SECOND PROCEDURE TO OBTAIN ADDITIONAL TISSUE SAMPLES.

  Patient problems: Insufficient Information

  MAUDE report 22110442 ↗