Leica ASP300 S - 230-240V 000000014047643514Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049188055972), received between Dec 18, 2020 and Dec 11, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Defective Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  ON 20 NOVEMBER 2025, THE CUSTOMER CONTACTED LEICA BIOSYSTEMS WITH THE FOLLOWING COMPLAINT: "THE TISSUE PROCESSOR COMPLETED THE PROCESS WITHOUT ERRORS BUT THE SAMPLES ARE TOO SOFT AND CANNOT BE CUT" ON 20 NOVEMBER 2025, THE LEICA HELP DESK SERVICE ENGINEER DOCUMENTED "THE CUSTOMER IS CURRENTLY REPROCESSING THE SPECIMENS AND WILL INFORM US IN THE COMING DAYS ABOUT THE OUTCOME." ON 25 NOVEMBER 2025,, THE LEICA HELP DESK SERVICE ENGINEER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION "THE SAMPLES AFTER CUTTING ARE NOT VERY GOOD; THEY APPEAR ¿VITRIFIED.¿ IN ANY CASE, NOT ALL OF THEM HAVE BEEN REPROCESSED YET, AND NONE HAVE REACHED THE DIAGNOSTIC STAGE SO FAR." ON 09 DECEMBER 2025, THE LEICA HELP DESK SERVICE ENGINEER DOCUMENTED "UNFORTUNATELY, NOT ALL SAMPLES ARE DIAGNOSABLE. I SPOKE WITH THE CUSTOMER ON FRIDAY AFTERNOON (YESTERDAY WAS A NATIONAL HOLIDAY IN ((YESTERDAY WAS A NATIONAL HOLIDAY IN ITALY), AND THEY MENTIONED THAT THE HEAD PHYSICIAN WAS ASSESSING HOW TO MANAGE THE SITUATION AND TRYING TO SAVE AS MANY SAMPLES AS POSSIBLE. HOWEVER, THEY CONFIRMED THAT NOT ALL OF THEM WOULD BE DIAGNOSABLE. I ASKED FOR AN APPROXIMATE ESTIMATE OF THE NUMBER OF LOST SAMPLES COMPARED TO THE TOTAL, B

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 23786091 ↗
• InjurySep 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 16 AUGUST 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR LEICA ASP300S. ON 24 AUGUST 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 4 BIOPSY SAMPLES COULD NOT BE DIAGNOSED.

  Patient problems: Tissue Breakdown

  MAUDE report 17797785 ↗
• InjuryFeb 12, 2021Defective Component; Defective Component

  ON 14 JANUARY 2021 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR (B)(4). AS A RESULT 3 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED, AND ON (B)(6) 2021 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT 3 PATIENTS HAVE TO BE REBIOPSIED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11320147 ↗
• InjuryFeb 12, 2021Defective Component; Defective Component

  ON (B)(6) LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP6025. AS A RESULT 3 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED, AND ON (B)(6) 2021 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT 3 PATIENTS HAVE TO BE REBIOPSIED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11320142 ↗
• InjuryDec 18, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem

  ON (B)(6) 2020, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED DAMAGED TISSUE SAMPLES DURING PROCESSING ON THEIR ASP300S. AS A RESULT TWO TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED. THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT TWO MEN WERE AFFECTED ABOUT THIS ADVERSE EVENT. THE AGE OF THE TWO DIFFERENT PATIENTS IS OVER 70 YEARS.

  Patient problems: Tissue Breakdown

  MAUDE report 11035169 ↗