Arthrex® AR-6068-90LRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867038950), received between May 15, 2024 and Mar 11, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionMar 11, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-6068-90L QUICKPASS LASSOS NITINOL WIRE WOULD NOT ADVANCE OUT OF THE LASSO DESPITE MULTIPLE ATTEMPTS. THIS OCCURRED DURING A CASE WITH NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572267 ↗
• MalfunctionJun 12, 2024Failure to Advance; Failure to Advance

  ON 02/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (14) AR-6068-90L QUICKPASS LASSOS, (9) AR-6068-90R QUICKPASS LASSOS WIRE INSIDE OF THE PASSERS OR COVERTURE ARE NOT ALLOWING THE LASSOS TO PASS THROUGH. THIS OCCURRED DURING A CASE. ADDITIONAL INFORMATION PROVIDED 2/15/2023: PER THE SALES REPRESENTATIVE THE PROCEDURE PERFORMED WAS A SHOULDER ARTHROSCOPY. THE ISSUE IS THAT THE WIRE IS NOT ABLE TO FACILITATE ALL THE WAY DOWN. THE CASE WAS COMPLETED BY USING A NEW AR-6068-90L FROM A DIFFERENT BATCH, LOT NUMBER NOT AVAILABLE. (QTY. 14) AR-6068-90L QUICKPASS LASSOS, (QTY. 9) AR-6068-90R QUICKPASS LASSOS WILL BE RETURNED BUT WERE NOT ALL USED IN THIS PARTICULAR CASE BUT HAS HAD THE SAME ISSUE IN OTHER CASES, WITH NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520650 ↗
• MalfunctionJun 11, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT AFTER THE PASSING WIRE WAS USED TO PASS THE SUTURE OF A KNOTLESS SUTURETAK, THE PASSING WIRE ITSELF WAS SEVERELY FRAYED AND WOULD NOT ENGAGE IN THE AR-6068-90L LASSO SO THE WIRE COULD NOT BE RETRACTED OR PUSHED OUT. A SECOND LASSO OF THE SAME LOT WAS OPENED FOR THE NEXT ANCHOR AND THE SAME EXACT PROBLEM OCCURRED. THE REP REPORTED NOTHING BROKE OFF INSIDE THE PATIENT. THE CASE WAS FINISHED BY USING A BIRDBEAK FOR SUTURE PASSING ON THE FINAL ANCHOR. THE REP STATED IT LOOKED AS IF SOMETHING IN THE LASSO WAS FRAYING THE PASSING WIRE AS IT WAS BEING PUSHED OUT BOTH TIMES. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515394 ↗
• MalfunctionJun 6, 2024Failure to Advance; Failure to Advance

  ON 08/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6068-90L QUICKPASS LASSO, AND A AR-6068-90R QUICKPASS LASSOS NYLON LOOP WASN'T COMING OUT THE LASSOS. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19478904 ↗
• MalfunctionMay 24, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE SURGERY. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 08-JUL-2021: IT WAS CONFRMED THAT NOTHING BROKE INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390717 ↗
• MalfunctionMay 23, 2024Difficult to Advance; Difficult to Advance

  ON 03/07/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT QTY. 2 OF AN AR-6068-90L 90°, CURVE, LEFT, QUICKPASS LASSO HAD AN ISSUE. THE SURGEON WAS PERFORMING A POSTERIOR LABRAL REPAIR OF A RIGHT SHOULDER ON (B)(6) 2022. A 90 CURVE LEFT QUICKPASS LASSO WAS OPENED TO PASS SUTURES IN THE 6 O'CLOCK POSITION. OUT OF THE PACKAGE, THE SCRUB TECH TRIED TO EXPEL THE NITINOL GUIDE WIRE, BUT IT WOULD NOT COME OUT THE TIP. THE SCRUB TECH THEN TOOK THE NITINOL GUIDE WIRE OUT OF THE PASSER AND TRIED TO LOAD THE PASSER AGAIN, BUT AGAIN IT WOULD NOT EXPEL OUT OF THE TIP. AFTER NUMEROUS ATTEMPTS, A SECOND 90 DEGREE CURVE LEFT QUICKPASS LASSO WAS OPENED. THIS LASSO HAD A SMALL AMOUNT OF NITINOL GUIDE WIRE HANGING OUT THE TIP, SO THIS WAS PULLED THROUGH THE TIP COMPLETELY AND TRIED TO RELOAD IT BUT THE PASSER ONCE AGAIN DID NOT EXPEL THE SUTURE. THE CASE WAS COMPLETED SUCCESSFULLY BY USING A CONMED SPECTRUM. THIS WAS DISCOVERED DURING THE UNBOXING OF THE COMPLAINT DEVICE WITH NO CASE/PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19385260 ↗
• MalfunctionMay 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 09/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-6068-90L QUICKPASS LASSO IS STUCK. THIS OCCURRED DURING A CASE WHEN OPENED THEY WERE UNABLE TO FEED THE WIRE THROUGH THE LASSO USING THE WHEELS. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19369547 ↗
• MalfunctionMay 21, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION SURGERY THE SUTURE PASSING WIRE DID NOT PASS THROUGH THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER MANUFACTURER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE SWIT 09-JAN-2022: A PDS-SUTURE WAS USED TO FINISH THE SURGERY SUCCESSFULLY, IT´S A DEVICE FROM A DIFFERENT MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360009 ↗
• MalfunctionMay 16, 2024Failure to Advance; Failure to Advance

  ON 10/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-6068-90L QUICKPASS LASSOS, AND A AR-6068-90R QUICKPASS LASSO ARE UNABLE TO PASS THE WIRE OUT THE END. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331178 ↗
• MalfunctionMay 16, 2024Failure to Advance; Failure to Advance

  ON 10/12/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-6068-90L QUICKPASS LASSOS, AND A AR-6068-90R QUICKPASS LASSO ARE UNABLE TO PASS THE WIRE OUT THE END. THIS OCCURRED DURING AN UNSPECIFIED TIME, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331139 ↗
• MalfunctionMay 15, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A BANKART SURGERY THE RETRIEVING WIRE WOULD NOT MOVE THROUGH THE DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320651 ↗