Arthrex® AR-4068-25TLRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888867031425), received between Apr 3, 2019 and Apr 20, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT DURING A SURGERY WHILE PIERCING THE LABRUM THE DEVICE BROKE OFF. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 08-APR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED ISSUE OCCURRED DURING A LABRUM STABILISATION. IT WAS FURTHER CONFIRMED THAT THE BROKEN PART WAS RETRIEVED OUT OF THE PATIENT AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926693 ↗
• MalfunctionMar 19, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY THE SUTURES GOT TORN. 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 24640013 ↗
• MalfunctionFeb 12, 2026Use of Device Problem

  ON (B)(6) 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4068-25TL, SUTURELASSO¿ SD, 25° TIGHT CURVE LEFT, SMOOTH SHUTTING WAS NOT ACHIEVED DUE TO THE INCONSISTENT WIRE LOOP THICKNESS. THIS WAS DETECTED DURING A RCR ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING IT TO ANOTHER AR-4068-25TL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324427 ↗
• MalfunctionFeb 9, 2026Use of Device Problem

  ON (B)(6)2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-4068-25TL, SUTURELASSO¿ SD, 25° TIGHT CURVE LEFT, IT HAS INCONSISTENT WIRE LOOP THICKNESS WHICH RESULT IN NOT ACHIEVING SMOOTH SHUTTLING. THIS WAS DETECTED DURING A RCR PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-4068-25TL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 22ND JAN 2026: THE ISSUE WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290981 ↗
• InjuryDec 31, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-4068-25TL SUTURE LASSO BROKE DURING SURGERY IN THE SHOULDER. IT WAS REPORTED THAT A WIDER INCISION HAD TO BE MADE TO REMOVE THE BROKEN PIECE, AND THE PATIENT WAS UNDER ANESTHESIA LONGER THAN NEEDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 23935696 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART LESION SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. 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 23921934 ↗
• MalfunctionDec 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 11/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-4068-25TL SUTURELASSO'S NITINOL WAS CUT. THIS WAS DISCOVERED DURING USE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744091 ↗
• MalfunctionJul 17, 2025Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE PLASTIC SLEEVE OF THE NITINOL WIRE CAME LOOSE. 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 22531086 ↗
• MalfunctionApr 23, 2025Break; Break

  ON 9TH APRIL 2025, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT FOR AN AR-4068-25TL, SUTURELASSO¿ SD, 25° TIGHT CURVE LEFT, THE METAL TIP OF SUTURE LASSO BROKE OFF WHILST TRYING TO PENETRATE THE LABRAL TISSUE. THIS WAS DETECTED DURING USE IN AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS A NEW SUTURE LASSO WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 21891838 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A BANKART SHOULDER SURGERY THE LOOP OF THE DEVICE BROKE DURING RETRACTION. 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 21060213 ↗
• MalfunctionOct 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE LASSO BROKE INSIDE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 20567590 ↗
• MalfunctionOct 16, 2024Break; Break

  ON (B)(6) 2024, A SALES REPRESENTATIVE VIA SEMS-06665104 REPORTED THAT AN AR-4068-25TL SUTURELASSO SD LOOP WAS BROKEN/NOT COMPLETE WHEN INSERTED INTO THE PATIENT. THIS OCCURRED WHEN THE SURGEON PASSED THE TIP OF THE SUTURELASSO AND THEN THUMBED THE NITINOL WIRE FORWARD TO EXPOSE THE LOOP. ONCE THE LOOP WAS EXPOSED, THE ISSUE WAS NOTICED. THE SURGEON HAD NOT TOUCHED IT WITH AN INSTRUMENT YET, WHICH WAS REPORTED DEFECTIVE FROM THE START. THEY OPENED AN ADDITIONAL SUTURELASSO AND PROCEEDED AS NORMAL TO COMPLETE THE CASE. THERE WAS NO EXTRA TIME ADDED OR HARM TO THE PATIENT. THIS WAS DISCOVERED DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 09/19/2024: THE BROKEN/INCOMPLETE AR-4068-25TL SUTURELASSO SD LOOP WAS REMOVED ENTIRELY FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460307 ↗
• MalfunctionOct 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR LABRAL STABILISATION SURGERY THE TIP OF THE DEVICE BROKE OFF. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. THE SURGEON SAID THAT HE WAS USING TOO MUCH FORCE AGAINST THE GLENOID. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE (25 DEGREE TIGHT CURVE SUTURE LASSO LEFT). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455597 ↗
• MalfunctionJun 7, 2024Failure to Advance; Failure to Advance

  ON 5/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-4068-25TL SUTURELASSO SD KEPT GETTING CLOGGED AND COULD NOT PASS THROUGH THEM. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/16/2024: THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE. AFTER THE TWO ISSUES, THEY OPENED UP A 45 DEGREE LASSO AND COMPLETED THE CASE. NOTHING BROKE OFF IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488651 ↗
• MalfunctionJun 7, 2024Failure to Advance; Failure to Advance

  ON 5/13/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-4068-25TL SUTURELASSO SD KEPT GETTING CLOGGED AND COULD NOT PASS THROUGH THEM. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 5/16/2024: THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE. AFTER THE TWO ISSUES, THEY OPENED UP A 45 DEGREE LASSO AND COMPLETED THE CASE. NOTHING BROKE OFF IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488400 ↗
• MalfunctionJun 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LABRUM REFIX SURGERY THE WIRE WAS TORN AT THE TIP OF THE DEVICE WHILE SHUTTLING THE THREAD. THE SURGEON WAS ABLE TO FINISH THE SURGERY SUCCESSFULLY WITH THE OTHER SIDE OF THE WIRE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476404 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED ON 06/10/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-4068-25TL SUTURE LASSO IS NOT CURVED CORRECTLY. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351762 ↗
• MalfunctionApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 04/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06531773 THAT AN AR-4068-25TL LASSO WIRE WOULD NOT PUSH FORWARD OUT OF THE CANNULA, GETTING STUCK AT THE DISTAL END OF THE SHAFT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19196582 ↗
• MalfunctionJul 5, 2022Break

  ON 6/17/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-4068-25TL SUTURELASSO SD NITINOL WIRE BROKE. THIS WAS DISCOVERED DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14914950 ↗
• MalfunctionJun 20, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-4068-25TL SUTURE LASSO BROKE. "SURGEON WAS PASSING THE SUTURE LASSO THROUGH THE ANTERIOR INFERIOR LABRAL TISSUE, AND THE TIP BROKE OFF." THIS WAS DISCOVERED DURING A CASE AND BROKE INSIDE THE JOINT.

  Patient problems: Insufficient Information

  MAUDE report 14743968 ↗
• MalfunctionJan 24, 2022Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC STABILIZATION SURGERY THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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: Foreign Body In Patient

  MAUDE report 13333665 ↗
• MalfunctionAug 18, 2021Break

  IT WAS REPORTED THAT DURING THE SURGERY WHILST TRYING TO PASS THE SUTURE LASSO THROUGH THE GLENOID LABRUM THE DISTAL 2CM OF THE LASSO BROKE OFF INSIDE THE PATIENT. IT WAS RECOVERED IN ITS ENTIRETY. X-RAYS WERE REQUIRED TO LOCATE THE FOREIGN BODY. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 09-AUG-2021: 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: Foreign Body In Patient

  MAUDE report 12335664 ↗
• MalfunctionJul 20, 2021Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROSCOPY IT WAS NOT POSSIBLE TO PULL THE WIRE LOOP WITH THE SUTURE RETRIEVER, AS THE WIRE LOOP OF THE DEVICE IMMEDIATELY TORE INSIDE THE PATIENT. NO PART OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT 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 12198254 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT DURING SHOULDER ARTHROSCOPY, THE TIP OF THE DEVICE BROKE INSIDE THE PATIENT. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 11724468 ↗
• InjurySep 4, 2019Break; Component Missing; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER RELEASING SCARRED LABRAL TISSUE, THE SUTURE LASSO WAS BEING USED TO CATCH 5 O'CLOCK POSITION. A 'SNAP' WAS HEARD AND WHEN THE SUTURE LASSO WAS PULLED OUT, THE TIP HAD BROKEN OFF. THE WIRE WAS PULLED OUT SLOWLY OUT OF A 7MM CRYSTAL CANNULA. PROCEDURE EVENTUALLY CONTINUED AND LABRAL REPAIR AND REMPLISSAGE WAS COMPLETED. X-RAY OF PATIENT WAS TAKEN INTRAOPERATIVELY WITH C-ARM AND PLAIN X-RAY WAS ORDERED AFTER PROCEDURE AND THE TIP COULDN'T BE FOUND IN THE IMAGE. ADDITIONAL INFORMATION RECEIVED AUGUST 12, 2019: THE SALES REP HAS REPORTED THAT IT IS POSSIBLE THE DEVICE TIP WAS SUCKED OUT WHILE USING SUCTION. THE TIP COULDN¿T BE PHYSICALLY LOCATED TO CONFIRM IT WAS NO LONGER IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959962 ↗