HistoCore PEGASUS 000000014048858005Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04049188216397), received between Apr 12, 2023 and Nov 19, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 10, 2024Open, Classified

   Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.

   Z-1947-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ON 05 NOVEMBER 2025, LEICA BIOSYSTEMS RECEIVED INFORMATION FROM THE CUSTOMER THAT SOME PATIENT CASES ARE NOT DIAGNOSABLE. NO FURTHER INFORMATION REGARDING THE NUMBER OF UNDIAGNOSABLE CASES OR PATIENT IMPACT HAS BEEN PROVIDED TO THE MANUFACTURER TO DATE. ON 23 OCTOBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "UNDER PROCESSED BIOPSY TISSUE ON BOTH RETORTS. THE RUNS COMPLETED WITH NO ERRORS." ON 31. OCTOBER, LEICA BIOSYSTEMS WAS INFORMED THAT THE AFFECTED SAMPLES HAD BEEN REPROCESSED. AT THIS TIME ADDITIONAL INFORMATION WAS PROVIDED STATING THAT SOME IMPACTED TISSUES STILL HAD TO BE DIAGNOSED. ON 05 NOVEMBER 2025, LEICA BIOSYSTEMS RECEIVED THE INFORMATION FROM THE CUSTOMER THAT THEY UNFORTUNATELY WILL HAVE SOME CASES THAT ARE NOT DIAGNOSABLE. THE CUSTOMER IS IN THE PROCESS OF DETERMINING WHAT CASES ARE NOT DIAGNOSABLE, AND THEY WILL THEY WILL INFORM THE LEICA BIOSYSTEMS TECHNICAL SPECIALIST ONCE THEY GET CONFIRMATION FROM THE PATHOLOGISTS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23591892 ↗
• InjuryOct 17, 2025Use of Device Problem; Device Ingredient or Reagent Problem; Use of Device Problem; Device Ingredient or Reagent Problem

  LEICA BIOSYSTEMS (LBS) RECEIVED A COMPLAINT OF UNDERPROCESSED TISSUE. ON 18 SEPTEMBER 2025, THE COMPLAINANT PROVIDED THE FOLLOWING INFORMATION TO LBS, "THERE WAS 1 CASE THAT WE WERE NOT ABLE TO GET A DEFINITIVE DIAGNOSIS. I HAVE NOT HEARD IF THEY ARE GOING TO RE-BIOPSY OR NOT THOUGH. I CAN MAKE SURE TO LET YOU KNOW ONCE I KNOW MORE." ON 23 SEPTEMBER 2025, THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT RECEIVED THE FOLLOWING UPDATE, "THE SUPERVISOR JUST SENT ME AN UPDATE. THERE WERE ACTUALLY 2 CASES THAT WERE UNABLE TO BE DIAGNOSED, AND THEY ARE GOING TO RE-BIOPSY." THE FOLLOWING IS THE FULL PATIENT IDENTIFIER INFORMATION FOR IMPORTER MDR 3022446399-2025-00010: FEMALE/59 SU25: MEN:3209. REFER TO IMPORTER MDR 3022446399-2025-00009 FOR INFORMATION ON THE FIRST PATIENT CASE IMPACTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23324738 ↗
• InjuryOct 17, 2025Use of Device Problem; Device Ingredient or Reagent Problem; Use of Device Problem; Device Ingredient or Reagent Problem

  LEICA BIOSYSTEMS (LBS) RECEIVED A COMPLAINT OF UNDERPROCESSED TISSUE. ON (B)(6) 2025, THE COMPLAINANT PROVIDED THE FOLLOWING INFORMATION TO LBS, "THERE WAS 1 CASE THAT WE WERE NOT ABLE TO GET A DEFINITIVE DIAGNOSIS. I HAVE NOT HEARD IF THEY ARE GOING TO RE-BIOPSY OR NOT THOUGH. I CAN MAKE SURE TO LET YOU KNOW ONCE I KNOW MORE." ON (B)(6) 2025, THE LBS FIELD APPLICATIONS SPECIALIST (FAS) INVESTIGATING THIS EVENT WITH THE COMPLAINANT RECEIVED THE FOLLOWING UPDATE, "THE SUPERVISOR JUST SENT ME AN UPDATE. THERE WERE ACTUALLY 2 CASES THAT WERE UNABLE TO BE DIAGNOSED, AND THEY ARE GOING TO RE-BIOPSY." THE FOLLOWING IS THE FULL PATIENT IDENTIFIER INFORMATION FOR IMPORTER MDR (B)(4): FEMALE/67 SU25:CM:3233. REFER TO IMPORTER MDR (B)(4) FOR INFORMATION ON THE SECOND PATIENT CASE IMPACTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23324720 ↗
• InjuryOct 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS TISSUE PROCESSOR. ACCORDING TO THE CUSTOMER, THERE WERE TWO RUNS PERFORMED ON (B)(6) 2025, AND ONE RUN PERFORMED ON (B)(6) 2025, WHICH WERE AFFECTED. THE TISSUE WAS DESCRIBED BY THE CUSTOMER AS UNDER PROCESSED. AFTER THE RUN PERFORMED ON (B)(6) 2025, THE CUSTOMER SUSPENDED THE USE OF THE DEVICE. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE PATIENT SAMPLE WAS UNABLE TO BE DIAGNOSED. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH RECEIVED FURTHER INFORMATION THAT THE NUMBER OF NON-DIAGNOSABLE CASES HAD INCREASED TO TWO AND THAT FOR BOTH CASES A RE-BIOPSY WOULD BE PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23308217 ↗
• InjuryOct 16, 2025Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  ON (B)(6) 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS TISSUE PROCESSOR. ACCORDING TO THE CUSTOMER, THERE WERE TWO RUNS PERFORMED ON (B)(6) 2025, AND ONE RUN PERFORMED ON (B)(6) 2025, WHICH WERE AFFECTED. THE TISSUE WAS DESCRIBED BY THE CUSTOMER AS UNDER PROCESSED. AFTER THE RUN PERFORMED ON (B)(6) 2025, THE CUSTOMER SUSPENDED THE USE OF THE DEVICE. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH WAS INFORMED THAT ONE PATIENT SAMPLE WAS UNABLE TO BE DIAGNOSED. ON (B)(6) 2025, LEICA BIOSYSTEMS NUSSLOCH GMBH RECEIVED FURTHER INFORMATION THAT THE NUMBER OF NON-DIAGNOSABLE CASES HAD INCREASED TO TWO AND THAT FOR BOTH CASES A RE-BIOPSY WOULD BE PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23308216 ↗
• InjuryJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGAUS, TISSUE PROCESSOR. AS A RESULT, 5 TISSUE SAMPLES WERE UNDIAGNOSABLE, AND FIVE PATIENTS NEED RE-BIOPSY.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 21206736 ↗
• InjuryDec 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 28 NOVEMBER 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS, TISSUE PROCESSOR. AS A RESULT THREE (3) TISSUES WERE UNDIAGNOSABLE.

  Patient problems: Insufficient Information

  MAUDE report 21025046 ↗
• InjurySep 18, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS, TISSUE PROCESSOR. AS A RESULT, 6 SIX) TISSUE SAMPLES WERE UNDIAGNOSABLE.

  Patient problems: Insufficient Information

  MAUDE report 20244640 ↗
• InjuryFeb 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 09 JANUARY 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS. AS A RESULT, 2 TISSUE SAMPLES NEED TO BE RECOLLECTED.

  Patient problems: Insufficient Information

  MAUDE report 18665108 ↗
• InjuryDec 22, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, THE COMPLAINANT CONTACTED LEICA AND DETAILED: "RETORT A TISSUE OVER PROCESSED, SLIDES NUCLEAR DETAILS ARE GONE. USER SUSPECTING SOME TYPE OF REAGENT CONTAMINATION, CARRY OVER ISSUE. HYDROMETER CHECK PERFORMED, ALL REAGENTS ARE WITHIN LIMITS. NO REAGENTS CHANGED. RETORT B TISSUE WAS FINE, AND IT WAS RUNNING AT AN HOUR APART, SAME PROTOCOL, SAME TYPE OF TISSUE." THE LAB HAS CHANGED ALL THE REAGENT INCLUDING WAX. THEY RAN TEST RUNS ON RETORT A ( 4 CASSETTES) AND RETORT B (1 CASSETTE), ALL TISSUE PROCESSED AS IT SHOULD. THEY WILL BE RUNNING MORE TESTS. THEY ARE SEEING NUCLEAR MELTDOWN WITH 150 SPECIMENS AFFECTED. THEY HAVE REQUESTED AN FSE ON SITE BEFORE THEY BEGIN TO USE THE PROCESSOR AGAIN. ON 20 DECEMBER 2023, LEICA BIOSYSTEMS NUSSLOCH RECEIVED THE FOLLOWING INFORMATION PROVIDED BY THE HISTOLOGY TECHNICAL SPECIALIST - CANADA TO THE LEICA BIOSYSTEMS SHANGHAI QUALITY ENGINEER: "DIAGNOSIS WAS MADE FOR ALL CASES HOWEVER 1 PROSTATE CASE ( 18 CASSETTES) WAS IMPACTED TO THE DEGREE IN WHICH ONE PATIENT WILL REQUIRE A REPEAT BIOPSY."

  Patient problems: Insufficient Information

  MAUDE report 18387677 ↗
• InjuryOct 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR ASP6025, TISSUE PROCESSOR. THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 20 TISSUE SAMPLES HAVE NOT BEEN DIAGNOSED.

  Patient problems: Insufficient Information

  MAUDE report 17929712 ↗
• InjuryOct 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023 LEICA BIOSYSTEMS (LBS) RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS. ON (B)(6) 2023, THE COMPLAINANT INITIALLY REPORTED TO LBS THAT ALL TISSUE WAS DIAGNOSABLE. HOWEVER, ON (B)(6) 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT IHC (IMMUNOHISTOCHEMISTRY) WAS UNABLE TO BE PROPERLY PERFORMED AND FURTHER RECOMMENDED RE-BIOPSY. ONE (1) BREAST SPECIMEN WAS NOT ENTIRELY DIAGNOSABLE DUE TO INABILITY TO RUN TESTING MARKER. WHEN ASKED IF THE STATE OF HEALTH OF THE PATIENT HAD BEEN ADVERSELY AFFECTED BY A MEDICAL DECISION OR ACTION EITHER TAKEN OR NOT TAKEN DUE TO THIS EVENT, THE COMPLAINANT REPLIED, "N/A ALTHOUGH DELAYS IN CARE, FULL DIAGNOSIS AND HAVING TO UNDERGO ANOTHER BIOPSY HAVE ALL OCCURRED."

  Patient problems: Insufficient Information

  MAUDE report 17892560 ↗
• InjuryOct 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE LEICA BIOSYSTEMS (LBS) MANUFACTURER CONDUCTED AN INVESTIGATION OF THIS EVENT AND DETERMINED THE INCIDENT WAS USER RELATED AND WAS MOST LIKELY CAUSED BY AN AIR TUBE BLOCKAGE, WHICH IN TURN CAUSED THE INSTRUMENT TO REPORT AN ERROR. THIS LED TO THE AFFECTED TISSUE SITTING IDLE FOR 2 HOURS IN XYLENE IN RETORT A AND CAUSED THE OBSERVED TISSUE DAMAGE TO OCCUR. BASED ON THE INVESTIGATION RESULTS AND THE ACTIONS CONDUCTED WITH THE INSTRUMENT AT THE CUSTOMER SITE, THE MANUFACTURER CONFIRMS THE INSTRUMENT, AT THIS TIME, IS WORKING ACCORDING TO FACTORY SPECIFICATIONS. TO AVOID A RECURRENCE OF THE SAME ISSUE IN THE FUTURE, A CUSTOMER FACING LETTER WAS SENT OUT TO THE CUSTOMER WITH RECOMMENDATIONS TO CONSIDER THE COUNTERMEASURES DEFINED IN THE INSTRUMENT INSTRUCTION FOR USE (IFU) REGARDING THE AIR TUBE BLOCKAGE. THE LBS MANUFACTURER'S REPORT, 8010478-2023-00011, CONTAINS ADDITIONAL INFORMATION REGARDING THE INVESTIGATION AND ROOT CAUSE.

  Patient problems: Insufficient Information

  MAUDE report 17886741 ↗
• InjuryApr 12, 2023Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023, THE COMPLAINANT CONTACTED LEICA BIOSYSTEMS AND REPORTED INCREASING FORMALIN FUMES IN THE TISSUE PROCESSOR, HISTOCORE PEGASUS AND THE CUT-UP ROOM IN THEIR HISTOPATHOLOGY ROOM. THE COMPLAINANT REPORTED THAT THEIR STAFF WERE FEELING LIGHT HEADED, NAUSEOUS, AND HAD HEADACHES.

  Patient problems: Chemical Exposure

  MAUDE report 16722353 ↗