SILVERGLIDE 6750250012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540532589), received between Mar 16, 2021 and Apr 25, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE GUIDE STOP WAS FOUND TO BE DISASSEMBLED FROM THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809042 ↗
• MalfunctionJan 14, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, A DEVICE TIP WAS FOUND TO BE MISSING SILVER PLATING MATERIAL, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261281 ↗
• MalfunctionMar 16, 2021Flaked; Flaked

  IT WAS REPORTED THAT IN THE STERILE PROCESSING DEPARTMENT AT THE USER FACILITY, A PIECE OF INSULATION WAS FOUND TO BE MISSING FROM THE DEVICE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497046 ↗