Arthrex® AR-6068-25TLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867038899), received between Apr 20, 2021 and Dec 24, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A CUSTOMER VIA EMAIL THAT FOR AN AR-6068-25TL, 25°, TIGHT CURVE, LEFT, QUICKPASS LASSO, SUTURE PASSER CURVED END SNAPPED OFF THE SHAFT DURING USE INSIDE THE PATIENT. THIS WAS DETECTED DURING USE IN A LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE BROKEN PIECE WAS RETRIEVED, AND THEY CONTINUED THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 23888223 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 12/03/2025, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6068-25TL 25-DEGREE TIGHT LEFT-CURVED QUICKPASS LASSO WAS BEING USED TO PASS THROUGH THE LABRUM. AFTER PASSING THROUGH, THERE WAS SCRAPING. THE DEVICE WAS TAKEN OUT AND INSPECTED. WHEN IT WENT BACK IN, IT SNAPPED. PART OF THE ITEM WAS REMOVED, BUT THE TIP REMAINED INSIDE THE PATIENT'S CAPSULE. THE BROKEN PIECE TOOK OVER TWO HOURS TO RETRIEVE FROM THE PATIENT, WHO SEEMS TO BE NORMAL AS OF NOW.

  Patient problems: Insufficient Information

  MAUDE report 23887388 ↗
• MalfunctionSep 16, 2025Material Frayed; Material Frayed

  ON 08/26/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-25TL QUICKPASS LASSO CABLES ARE FRAYED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063068 ↗
• MalfunctionOct 3, 2024Break; Break

  ON 09/13/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-6068-25TL 25° TIGHT CURVE, LEFT, QUICKPASS LASSO HAD THE TIP BREAK OFF IN THE PATIENT'S SHOULDER. THE SURGEON RETRIEVED THE BROKEN PIECE. THE CASE WAS COMPLETED BY FINISHING REPAIRING THE LABRUM AS INTENDED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 09/18/2024: THE CASE WAS DELAYED UNTIL THEY OPENED A NEW QUICK PASS AND WAS NOT LONG. THIS WAS DISCOVERED DURING A ANTERIOR LABRAL REPAIR PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358938 ↗
• MalfunctionSep 9, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC STABILISATION OF GLENOHUMERAL JOINT THE TIP OF THE LASSO BROKE OFF AS THE SURGEON WAS TRYING TO PASS THE DEVICE THROUGH THE LABRAL TISSUE. THE BREAK WAS WHERE THE TIP IS WELDED TO THE SHAFT OF THE LASSO. SURGEON ADMITTED HE MAY HAVE PUT TOO MUCH PRESSURE ON THE DEVICE WHEN IT WAS CONTACTING THE BONE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER (SMITH & NEPHEW ACCUPASS). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169624 ↗
• MalfunctionJun 21, 2024Failure to Advance; Failure to Advance

  ON 05/23/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-6068-25TL 25°, TIGHT CURVE, LEFT, QUICKPASS, HAD A LASSO THAT WAS STUCK OR CAUGHT ON SOMETHING ON THE INSIDE. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583784 ↗
• MalfunctionMay 16, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 10/24/2022 BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-6068-25TL SUTURE LASSO WIRE STOPPED TURNING THE ROLLER. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19332154 ↗
• MalfunctionNov 21, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORT THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS, THE DEVICE BLOCKED AND THE SURGEON WAS NOT ABLE TO PULL THE SUTURE. 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 18180689 ↗
• MalfunctionOct 17, 2023Defective Device; Defective Device

  ON 25TH SEPTEMBER 2023, IT WAS REPORTED BY ARTHREX EMPLOYEE VIA EMAIL THAT 2 PIECES OF AR-6068-25TR, 25°, TIGHT CURVE, RIGHT, QUICK PASS LASSO AND 2 PIECES OF AR-6068-25TL, 25°, TIGHT CURVE, LEFT, QUICK PASS LASSO WERE NOT FEEDING WIRE. THESE WERE DETECTED AT AN UNSPECIFIED TIME ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17951824 ↗
• MalfunctionApr 28, 2023Break; Break

  IT WAS REPORTED ON 03/31/2023 BY A SALES REPRESENTATIVE VIA SEMS, THAT AN AR-6068-25TL SUTURE LASSO TIP BROKE OFF, JUST PROXIMAL TO THE BEND AS THE SURGEON WAS TRYING TO PASS THE LASSO THROUGH THE SHOULDER CAPSULAR TISSUE. CASE INVOLVEMENT, DEVICE BROKE DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838935 ↗
• MalfunctionApr 20, 2021Break

  IT WAS REPORTED THAT A QUANTITY TWO AR-6068-25TL (LOT: 000399887) BROKE RIGHT AT THE END OF THE SHAFT.

  Patient problems: Insufficient Information

  MAUDE report 11692665 ↗