KALTOSTAT 168210Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00768455122783), received between Dec 27, 2021 and Jul 25, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388482 ↗
• MalfunctionSep 20, 2022Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Contamination /Decontamination Problem; Device Contaminated During Manufacture or Shipping

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454028 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CLINICIAN TO THE TERRITORY MANAGER THAT ONE OUT OF ONE DRESSING ON ONE PATIENT WAS STICKING AND HAD DIFFICULTY IN REMOVAL. THIS PRODUCT WAS REGULARLY USED AT THIS MEDICAL FACILITY. PRODUCT WAS BEING PLACED ON SKIN DONOR SITES. NO PRIOR ISSUES AT THIS FACILITY WITH THIS PRODUCT HAVE BEEN REPORTED BEFORE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798221 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CLINICIAN TO THE TERRITORY MANAGER THAT ONE OUT OF ONE DRESSING ON ONE PATIENT WAS STICKING AND HAD DIFFICULTY IN REMOVAL. THIS PRODUCT WAS REGULARLY USED AT THIS MEDICAL FACILITY. PRODUCT WAS BEING PLACED ON SKIN DONOR SITES. NO PRIOR ISSUES AT THIS FACILITY WITH THIS PRODUCT HAVE BEEN REPORTED BEFORE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798220 ↗
• MalfunctionJun 24, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY CLINICIAN TO THE TERRITORY MANAGER THAT ONE OUT OF ONE DRESSING ON ONE PATIENT WAS STICKING AND HAD DIFFICULTY IN REMOVAL. THIS PRODUCT WAS REGULARLY USED AT THIS MEDICAL FACILITY. PRODUCT WAS BEING PLACED ON SKIN DONOR SITES. NO PRIOR ISSUES AT THIS FACILITY WITH THIS PRODUCT HAVE BEEN REPORTED BEFORE. NO PHOTO IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798214 ↗
• MalfunctionDec 27, 2021Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087145 ↗
• MalfunctionDec 27, 2021Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087112 ↗