Stablecut® 11-3586Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024494046), received between Apr 17, 2023 and Apr 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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.

• MalfunctionApr 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INSPECTION THE DEVICE HAD A FOREIGN SUBSTANCE IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885094 ↗
• MalfunctionFeb 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469182 ↗
• MalfunctionNov 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, ON AN UNKNOWN DATE, THE PRODUCT WAS FOUND TO BE NONCONFORMING AS A FOREIGN SUBSTANCE WAS NOTED IN THE PACKAGE. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROGRESS AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662793 ↗
• MalfunctionApr 17, 2023Break; Loose or Intermittent Connection; Detachment of Device or Device Component; Material Twisted/Bent; Break; Loose or Intermittent Connection; Detachment of Device or Device Component; Material Twisted/Bent

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753732 ↗