Arthrex® AR-6068-90TRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867038974), received between Mar 28, 2022 and Nov 13, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY IT WAS DIFFICULT TO DELIVER THE SUTURE WITH THE LASSO. 2 PRODUCTS WITH THE SAME BATCH/LOT (AR-6068-90T/4247152361) WERE TRIED. NO PART OF THE DEVICES BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541693 ↗
• MalfunctionNov 13, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY SURGERY IT WAS DIFFICULT TO DELIVER THE SUTURE WITH THE LASSO. 2 PRODUCTS WITH THE SAME BATCH/LOT (AR-6068-90T/4247152361) WERE TRIED. NO PART OF THE DEVICES BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541557 ↗
• MalfunctionDec 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068-90T QUICKPASS LASSO BROKE. THIS OCCURRED DURING A BONY BANKART PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20864795 ↗
• MalfunctionMay 24, 2024Defective Device; Defective Device

  ON 08/26/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068-60T 90 DEG QUICKPASS LASSO WAS BOUND UP OUT OF THE PACKAGE. THIS WAS DISCOVERED DURING USE IN A SHOULDER PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED WITH A AR-6068-90T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392209 ↗
• MalfunctionApr 30, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR IT WAS FOUND THAT THE CURVATURE OF THE QUICKPASS SUTURE LASSO IS TOO MUCH CURVED. IT WAS FURTHER REPORTED THAT DUE TO THIS FAILURE IT IS NOT POSSIBLE TO PASS THROUGH A PORTAL WITH AN INNER DIAMETER OF 7MM. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213356 ↗
• MalfunctionMar 28, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-6068-90T 90 DEG. TIGHT CURVE QUICKPASS LASSO HAD AN ISSUE. THE SD WIRE LOOP BROKE WHEN THE DOCTOR PULLED IT OUT AFTER HOOKING THE FIRST STITCH DURING A PROCEDURE ON (B)(6) 2022. USED A NEW PRODUCT AND THE CASE WAS COMPLETED. NO PATIENT HARM. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON (B)(6) 2022, THE ARTHREX EMPLOYEE STATED THE FOLLOWING INFORMATION VIA EMAIL: THIS EVENT OCCURRED DURING AN ARCR PROCEDURE. THE WIRE LOOP BROKE INSIDE THE PATIENT, ALL FRAGMENTS WERE RETRIEVED AND REMOVED. THIS WAS A QUICK PASS DEVICE AND WAS ONLY RELOADED ONCE. THERE WAS NO AFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928413 ↗