ACCU-PASS 7210427Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010534484), received between Apr 5, 2021 and Apr 5, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING SETUP FOR A SHOULDER ARTHROSCOPY, THE ACCU-PASS STR SHUTTLE CRESCENT WAS NOT FITTING THROUGH THE WHEELS. THERE WAS BACKUP DEVICE AVAILABLE AND NO DELAY OR COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614376 ↗