KALTOSTAT 168117Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00768455122776), received between Sep 16, 2021 and Jan 19, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem

  THE END USER REPORTED THAT ONE OF THE DRESSING WAS OPENED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS ALSO RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541776 ↗
• MalfunctionJan 6, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111154 ↗
• MalfunctionSep 16, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DOCTOR FOUND THE FIBER OF KALTOSTAT WAS DIFFICULT TO REMOVE FROM THE SURGERY WOUND. THE DRESSING FIBER WAS NOT STRONG ENOUGH WHEN REMOVED FROM WOUND SO IT HAD SOME DRESSING RESIDUE IN THE WOUND. THE PRODUCT WAS USED FOR LESS THAN 7 DAYS. NO HARM WAS REPORTED TO THE PATIENT. A PHOTOGRAPH WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479383 ↗
• MalfunctionSep 16, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DOCTOR FOUND THE FIBER OF KALTOSTAT WAS DIFFICULT TO REMOVE FROM THE SURGERY WOUND. THE DRESSING FIBER WAS NOT STRONG ENOUGH WHEN REMOVED FROM WOUND SO IT HAD SOME DRESSING RESIDUE IN THE WOUND. THE PRODUCT WAS USED FOR LESS THAN 7 DAYS. NO HARM WAS REPORTED TO THE PATIENT. A PHOTOGRAPH WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479381 ↗