Arthrex® AR-6068-25TRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867038905), received between Oct 17, 2023 and Aug 26, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461758 ↗
• MalfunctionAug 25, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50437758 ↗
• MalfunctionJul 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25802703 ↗
• MalfunctionDec 10, 2025Material Frayed; Material Frayed

  ON 11/24/2025, A SALES REPRESENTATIVE REPORTED THAT AN AR-6068-25TR 25°, TIGHT CURVE, RIGHT, QUICKPASS LASSO EXPERIENCED AN ISSUE DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2025. THE PLASTIC CASING AROUND THE NITINOL WIRE FRAYED INTRAOPERATIVELY INSIDE THE PATIENT, WITH THE PLASTIC CASING AROUND THE NITINOL WIRE DELAMINATED, RENDERING THE DEVICE UNUSABLE. THE BROKEN FRAGMENT WAS RETRIEVED, AND THERE WAS NO PATIENT HARM OR SIGNIFICANT PROCEDURAL DELAY. ADDITIONAL OBSERVATIONS INCLUDED THAT THE LASSO WHEEL FELT ROUGH OUT OF THE BOX. THE CASE WAS COMPLETED USING A REPLACEMENT AR-6068-25TR DEVICE. NO DETAILS REGARDING BONE PREPARATION OR BONE QUALITY WERE DOCUMENTED. ADDITIONAL INFORMATION WAS RECEIVED ON 11/26/2025: THE AR-6068-25TR 25°, TIGHT CURVE, RIGHT, QUICKPASS LASSO DEVICE EXHIBITED FRAYING AND DELAMINATION OF THE PLASTIC CASING AROUND THE NITINOL WIRE ON FIRST USE WHILE BEING DEPLOYED THROUGH THE LABRAL TISSUE. THE SURGEON NOTED THAT THE WHEELS FELT ROUGH PRIOR TO INSERTION. NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA OCCURRED, AS A SECOND DEVICE WAS AVAILABLE AND USED. NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23770278 ↗
• MalfunctionDec 3, 2025Material Frayed; Material Frayed

  ON 11/13/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-6068-25TR 25-DEGREE TIGHT RIGHT-CURVED QUICKPASS LASSO PLASTIC CASING AROUND THE NITINOL WIRE FRAYED INTRAOPERATIVELY, MAKING IT UNUSABLE DURING A LABRAL REPAIR. THEY OPENED A NEW AR-6068-25TR SUTURELASSO TO COMPLETE THE CASE. THERE WAS NO HARM DONE TO THE PATIENT, NOR WAS THERE ANY SIGNIFICANT PROCEDURAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705777 ↗
• MalfunctionJul 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 07/08/2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-6068-25TR QUICKPASS LASSO TIP CAME OFF. THIS OCCURRED DURING A BANKART REPAIR. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22663903 ↗
• MalfunctionMar 21, 2025Break; Break

  ON 03/10/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068-25TR 25°, TIGHT CURVE, RIGHT, QUICKPASS LASSO HAD THE HEAD OF THE LASSO SNAPPED OFF WHILE TRYING TO PASS AROUND THE LABRUM. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6)2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03/14/2025: THERE WAS A 15 MINUTE DELAY TO GET THE BROKEN PIECE OUT OF THE SHOULDER. THERE WAS AN EXTRA 15 MINUTES OF ADDED ANESTHESIA ADMINISTERED. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-6068-25TR. THERE WAS NO REPORT OF NEGATIVE EFFECTS ON OR AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664066 ↗
• MalfunctionJan 2, 2025Break; Break

  ON 12/06/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068-25TR QUICKPASS LASSO TIP BROKE OFF. THIS OCCURRED DURING USE IN A LABRUM REPAIR CASE WITH NO PATIENT EFFECT. THERE WAS A 20 MINUTE DELAY WHILE TRYING TO RETRIEVE THE NEEDLE. ALL FRAGMENTS ABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21056811 ↗
• MalfunctionOct 10, 2024Failure to Advance; Failure to Advance

  ON 19 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-6068-90R 90 DEG CURVE RIGHT, QUICKPASS LASSO WAS REPORTED TO NOT FUNCTION CORRECTLY DURING A CASE. THIS OCCURRED ON 19 SEPTEMBER 2024 IN (B)(6) DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE 90 DEGREE QUICKPASS LASSO WAS OPENED AND THE SCRUB NURSE CHECKED THE WIRE LOOP WAS ADVANCING, THE SURGEON PUT THE LASSO THROUGH THE LABRAL TISSUE AND THEN COULD NOT GET THE WIRE LOOP TO ADVANCE. TROUBLESHOOTING WAS PERFORMED TO ASCERTAIN WHETHER TISSUE WAS BLOCKING THE TIP OF WHICH IT WAS NOT. THE WIRE LOOP THEN PROCEEDED TO COME OUT OF THE DEVICE AT THE ROLLER WHEEL. ANOTHER QUICKPASS LASSO (25 DEGREE) WAS THEN OPENED. WHEN THE SURGEON FED THE LOOP OUT OF THE LASSO IT WOULD NOT ADVANCE PAST THE END OF THE LOOP. THE SURGEON WAS USING A SINGLE PORTAL TECHNIQUE SO IT WAS NOT POSSIBLE TO GRASP THE LOOP WITH A GRASPER WHICH WOULD HAVE RELEASED THE RESISTANCE OF THE WIRE LOOP TO ADVANCE. THE CASE WAS COMPLETED SUCCESSFULLY. THE WIRE LOOP FROM THE LASSO WAS INSERTED BACKWARDS AND RETRIEVED USING A GRASPER AND THEN THE SUTURE WAS SHUTTLED THROUGH THE LABRUM. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20416471 ↗
• 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, QUICKPASS LASSO AND 2 PIECES OF AR-6068-25TL, 25°, TIGHT CURVE, LEFT, QUICKPASS LASSO WERE NOT FEEDING WIRE. THESE WERE DETECTED AT AN UNSPECIFIED TIME ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17950007 ↗