Avitene 1050050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741010552), received between Jul 6, 2023 and Aug 10, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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. 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.

• MalfunctionAug 10, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, THE PHYSICIAN USED AVITENE ULTRAFOAM DURING A PROCEDURE, BUT THE PRODUCT FAILED TO ACHIEVE HEMOSTASIS EFFECTIVELY IN APPLICATION. THE PRODUCT WAS REPORTED TO HAVE MADE CONTACT WITH THE PATIENT BODY FLUIDS. THERE WAS NO HARM TO PATIENT. IT WAS REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498043 ↗
• MalfunctionJul 6, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED AVITENE ULTRAFOAM. IT WAS REPORTED THAT THE PRODUCT FAILED TO ACHIEVE HEMOSTASIS EFFECTIVELY IN APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266999 ↗