SILVERGLIDE 6720240007Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04546540532329), received between Aug 16, 2018 and Jul 14, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Flaked” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Flaked; Flaked

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THE SILVER COATING WAS FLAKED OFF BOTH TIPS OF THE DEVICE, POSING THE RISK OF 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 22493875 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THE GUIDE STOP WAS FRACTURED OFF AND MISSING FROM THE DEVICE DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460775 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED ONE OF THE TIPS OF THE DEVICE WAS OBSERVED TO BE FRACTURED OFF AND MISSING DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22419916 ↗
• MalfunctionFeb 12, 2025Flaked; Flaked

  IT WAS REPORTED DURING TESTING AT THE USER FACILITY MATERIAL WAS OBSERVED TO BE PEELED OFF THE TIPS OF THE DEVICE, POSING THE RISK OF 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 21365908 ↗
• MalfunctionFeb 12, 2025Flaked; Flaked

  IT WAS REPORTED DURING TESTING AT THE USER FACILITY MATERIAL WAS OBSERVED TO BE PEELED OFF THE TIPS OF THE DEVICE, POSING THE RISK OF 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 21365906 ↗
• MalfunctionFeb 12, 2025Flaked; Flaked

  IT WAS REPORTED DURING TESTING AT THE USER FACILITY MATERIAL WAS OBSERVED TO BE PEELED OFF THE TIPS OF THE DEVICE, POSING THE RISK OF 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 21365905 ↗
• MalfunctionDec 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER SERVICE TECHNICIAN REPORTED THE GUIDESTOP WAS FRACTURED OFF AND MISSING FROM THE DEVICE DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891971 ↗
• MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE TIP WAS FOUND TO BE FRACTURED OFF AND MISSING FROM THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A SERVICE EVALUATION AT THE MANUFACTURER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750804 ↗
• MalfunctionNov 17, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE INSULATION WAS FOUND TO BE COMING OFF 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 15820102 ↗
• MalfunctionNov 17, 2022Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE INSULATION WAS FOUND TO BE COMING OFF 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 15819746 ↗
• MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE TIP WAS FOUND TO BE FRACTURED OFF AND MISSING FROM THE DEVICE, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A TESTING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15599200 ↗
• MalfunctionAug 16, 2018Material Fragmentation; Material Fragmentation

  THE DEVICE GUIDESTOP SCREW HAD BROKEN, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING STERILE PROCESSING AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7789052 ↗