BIOSTOP 5463-60-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295174721), received between Feb 24, 2020 and Jan 8, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

• MalfunctionJan 8, 2021Unintended Movement; Unintended Movement

  WHEN THE NURSE WENT TO PUT THERE TRIAL ON THE BIOSTOP INSERTER HANDLE. THERE WAS SOME PLAY AND THE TRIAL FELT LOOSE. IT WAS NEVER LIKE THAT. MOST LIKELY DUE TO OVER USAGE. THE HANDLE SHOULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139365 ↗
• MalfunctionApr 24, 2020Material Twisted/Bent; Material Twisted/Bent

  UPON THE USE OF THE T HANDLE FROM THE BIOSTOP INSTRUMENTS, THE THREADED SCREW ON TIP THAT ENGAGES WITH THE TRIAL, CROSS THREADED TOGETHER. THIS HAPPENED AFTER TRAILING WAS DONE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996104 ↗
• MalfunctionFeb 24, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  WHEN OPENING THE CEMENT RESTRICTOR FOR A BIPOLAR CASE THIS MORNING, WE SAW THAT THE CEMENT RESTRICTOR INSERTER WAS BENT. THERE IS A DEPTH GAUGE THAT CAN SLIDE DOWN TO MEASURE THE DEPTH OF INSERTION, BUT IT WASN'T ABLE TO GO PAST HALF WAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746372 ↗