Arthrex® AR-4065-45RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867031340), received between Jun 4, 2024 and Mar 13, 2026 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Twisted/Bent

  ON (B)(6), A SALES REPRESENTATIVE REPORTED VIA SEMS(B)(4) THAT THE AR-4065-45R CORKSCREW SUTURE LASSO COULD NOT BE USED AS THE TIP WAS EITHER TOO TIGHT OR BENT, THE LASSO WIRE WOULD NOT PASS THROUGH. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591501 ↗
• MalfunctionJun 4, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ON 11/18/2022 BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-4065-45R SUTURE LASSO BENT. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19458558 ↗