Stablecut® 11-3501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024493872), received between Jun 4, 2024 and Feb 4, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NONCONFORMING AS THERE WAS A FOREIGN SUBSTANCE ON IT. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307640 ↗
• MalfunctionJun 4, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, DEBRIS FOUND IN PACKAGING. NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458819 ↗