BICEPTOR 72202189Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010621542), received between Oct 7, 2019 and Jul 11, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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.

• MalfunctionJul 11, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, IT WAS FOUND THAT THE PLASTIC PROTECTIVE SLIP OF THE WIRE GUIDE WAS STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10261820 ↗
• MalfunctionOct 7, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGERY THE PLASTIC CAP THAT IS ON GUIDE WIRE, LEFT PLASTIC DEBRIS ON THE WIRE WHEN IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACK-UP DEVICE. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9161358 ↗