HistoCore PEGASUS Plus 000000014048858007Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04049188217769), received between Mar 31, 2023 and Aug 4, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Improper or Incorrect Procedure or Method

  On (b)(6) 2026, the customer contacted Leica Biosystems and reported "a processing quality issue affecting small tissue specimens, including endoscopic and biopsy samples. During histological quality control, alterations were observed primarily in nuclear definition, which could potentially impact diagnostic evaluation."On (b)(6) 2026, the Leica representative advised "According to the customer, although the affected samples presented processing quality issues that mainly impacted nuclear visibility, all affected cases were reviewed and reported by experienced pathologists. The report also indicates that no re-biopsies were required and that no patient harm was identified."On (b)(6) 2026, the customer advised the impact to patients had been updated and provided the following information "All affected cases required additional tissue sections and repeat H&E staining. The customer confirmed that eight cases could not be reported for hormone receptor evaluation and that one core biopsy could not be diagnosed. A repeat biopsy was performed, and the customer confirmed that the event resulted in delays in patient diagnosis and patient care." Identifiers for the affected patients were req

  Patient problems: Insufficient Information

  MAUDE report 50132712 ↗
• MalfunctionApr 17, 2024Contamination; Insufficient Device Problem Information; Contamination; Insufficient Device Problem Information

  ON (B)(6) 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT ABOUT BAD SAMPLE QUALITY OF TISSUES PROCESSED ON A HISTOCORE PEGASUS PLUS TISSUE PROCESSOR. THE TISSUE SAMPLES HAD BEEN PROCESSED OVER NIGHT ON (B)(6) 2024.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19123912 ↗
• InjuryApr 9, 2024Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information; Use of Incorrect Control/Treatment Settings; Insufficient Device Problem Information

  ON 11 MARCH 2024 LEICA BIOSYSTEMS RECEIVED A COMPLAINT ABOUT A DENSITOMETER ERROR OF THE HISTOCORE PEGASUS PLUS, TISSUE PROCESSOR. ON 25 MARCH 2024 FURTHER INFORMATION WAS RECEIVED THAT SAMPLES THAT HAD BEEN PROCESSED ON THE TISSUE PROCESSOR ON (B)(6) 2024, (B)(6) 2024 AND (B)(6) 2024 WERE NEGATIVELY IMPACTED AND HAD A BURNT APPEARANCE UNDER THE MICROSCOPE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 19069646 ↗
• InjuryApr 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 08 MARCH 2024, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS PLUS, TISSUE PROCESSOR. THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 1 TISSUE SAMPLE HAVE NOT BEEN DIAGNOSED.

  Patient problems: Insufficient Information

  MAUDE report 19056906 ↗
• InjuryDec 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 06 DECEMBER 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS PLUS. AS A RESULT, 6 SAMPLES NEEDED TO BE RECOLLECTED.

  Patient problems: Insufficient Information

  MAUDE report 18363126 ↗
• InjurySep 15, 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 HISTOCORE PEGASUS PLUS. ON (B)(6) 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 1 BREAST CORE BX SAMPLE HAS NOT BEEN FULLY DIAGNOSED.

  Patient problems: Tissue Breakdown

  MAUDE report 17754382 ↗
• InjuryAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 07 AUGUST 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS PLUS. AS A RESULT, 22 SAMPLES NEEDED TO BE RECOLLECTED.

  Patient problems: Tissue Breakdown

  MAUDE report 17572156 ↗
• InjuryJun 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 05 APRIL 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS PLUS, TISSUE PROCESSOR. AS A RESULT, 250 CASSETTES WITH TISSUE SAMPLES WERE AFFECTED.

  Patient problems: Tissue Breakdown

  MAUDE report 17236342 ↗
• InjuryMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 21 FEBRUARY 2023 LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR HISTOCORE PEGASUS PLUS. ON 03 MARCH 2023 THE CUSTOMER INFORMED LEICA BIOSYSTEMS, THAT AS A RESULT, 1 TISSUE SKIN SAMPLE HAS NOT BEEN DIAGNOSED.

  Patient problems: Tissue Breakdown

  MAUDE report 16654404 ↗