SILVERGLIDE 6750230015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540532541), received between Jun 12, 2020 and Aug 14, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2020Flaked; Flaked

  DURING TESTING AT THE USER FACILITY, IT WAS REPORTED THAT PIECES OF INSULATION WERE FOUND TO BE MISSING FROM THE DEVICE, POSING THE RISK OF A MATERIAL BEING LOST IN A SURGICAL SITE. 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; No Patient Involvement

  MAUDE report 10409739 ↗
• MalfunctionJun 12, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING TESTING BY THE MANUFACTURER SALES REPRESENTATIVE AT THE USER FACILITY, THE DEVICE TIPS WERE FOUND TO BE CHIPPED, 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; No Patient Involvement

  MAUDE report 10149364 ↗