Arthrex® AR-7535Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867288669), received between Aug 11, 2020 and Mar 5, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Device Damaged by Another Device

  ON 13-FEB-2026, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT A QTY. 7 OF AR-7250 FIBERWIRE #0, A QTY. 5 OF AR-7200 FIBERWIRE #2, A QTY. 1 OF AR-7535 FIBERLINK SUTURE TAPE WERE BEING CUT BY AN AR-12990N SCORPION NEEDLE DURING A MENISCAL ROOT REPAIR PROCEDURE. ANOTHER AR-12990N NEEDLE WAS OPENED BUT CONTINUED TO CUT THE SUTURES. AN AR-4068-90 SUTURE LASSO WAS THEN USED AS AN ALTERNATIVE TO TRY AND PASS THE SUTURES THROUGH TISSUE BUT WAS ALSO UNSUCCESSFUL. THE CASE WAS COMPLETED SUCCESSFULLY WITH A SHOULDER SCORPION. NO PATIENT HARM WAS REPORTED, AND NO PIECES BROKE OFF INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519920 ↗
• MalfunctionApr 18, 2025Use of Device Problem; Use of Device Problem

  ON 04/01/2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA (B)(6) THAT AN AR-12990N SCORPION NEEDLE AND AN AR-7535 EXPERIENCED AN ISSUE. WHEN THE NEEDLE WAS INSTALLED TO THE SCORPION AND TRIED TO THREAD TAPE, THE HANDLE WAS TOO STIFF TO GRIP. UPON CHECKING, THE NEEDLE HAD BROKEN OFF IN THE SHAFT. THIS WAS DISCOVERED DURING THE CASE AND THE CASE WAS COMPLETED USING ANOTHER DEVICE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866353 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-4068-45L SUTURELASSO¿ SD HAD AN ISSUE WHILE SHUTTLING AN AR-7535 FIBERLINK SUTURETAPE STITCH. THE SURGEON PASSED THE SD SUTURE LASSO AROUND THE LABRUM AND LEFT THE SD WIRE IN PLACE TO SHUTTLE A STITCH AROUND. UPON SHUTTLING, A STITCH THROUGH THE WIRE LOOP BROKE, AND THE SURGEON RETRIEVED THE STITCH (AR-7535 FIBERLINK SUTURETAPE) AROUND THE LABRUM. NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON INSERTED THE PUSHLOCK ANCHOR (AR-2923BC) TO COMPLETE THAT PART OF THE REPAIR. THIS ISSUE HAPPENED TWICE MORE DURING THE CASE (SEE PHOTOS). THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/14/2024: THE WIRE LOOP OF THE (QTY. 2) OF AN AR-4068-45L SUTURELASSO DID NOT BREAK, AND NO PIECES BROKE OFF. THERE WAS NO CASE DELAY REPORTED. NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084996 ↗
• MalfunctionJan 6, 2025Break; Break

  ON 12/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT (QTY. 2) OF AN AR-4068-45L SUTURELASSO¿ SD HAD AN ISSUE WHILE SHUTTLING AN AR-7535 FIBERLINK SUTURETAPE STITCH. THE SURGEON PASSED THE SD SUTURE LASSO AROUND THE LABRUM AND LEFT THE SD WIRE IN PLACE TO SHUTTLE A STITCH AROUND. UPON SHUTTLING, A STITCH THROUGH THE WIRE LOOP BROKE, AND THE SURGEON RETRIEVED THE STITCH (AR-7535 FIBERLINK SUTURETAPE) AROUND THE LABRUM. NO PIECES BROKE OFF INSIDE THE PATIENT. THE SURGEON INSERTED THE PUSHLOCK ANCHOR (AR-2923BC) TO COMPLETE THAT PART OF THE REPAIR. THIS ISSUE HAPPENED TWICE MORE DURING THE CASE (SEE PHOTOS). THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/14/2024: THE WIRE LOOP OF THE (QTY. 2) OF AN AR-4068-45L SUTURELASSO DID NOT BREAK, AND NO PIECES BROKE OFF. THERE WAS NO CASE DELAY REPORTED. NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084992 ↗
• MalfunctionApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 9/29/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN WHILE USING AN AR-3680 FIBERTAK BUTTON KIT, THE IMPLANT PULLED OUT. SURGEON OPENED AN AR-3681 FIBERTAK BUTTON ALONG WITH AN AR-7535 FIBERLINK SUTURE TAPE WHICH ALSO PULLED OUT. FINALLY CASE WAS COMPLETED WITH A PRODUCT FROM ANOTHER MANUFACTURER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 10/4/2022: THIS WAS DISCOVERED DURING AN RCR PROCEDURE AND NOTHING BROKE INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19079127 ↗
• InjuryMar 28, 2022Material Frayed

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPSLC PEEK KNOTLESS SWIVELOCK SEEMS TO BE FRAYING AND CUTTING AN AR-7535 FIBERLINK SUTURE TAPE SUTURE WHEN THE SUTURE COMES IN CONTACT WITH THE METAL DRIVER DURING TENSIONING. THIS WAS DISCOVERED DURING A REVISION SUBPEC TENODESIS PROCEDURE ON (B)(6) 2022. THIS ISSUE HAS CAUSED THE BICEP TO RETRACT AND CAUSING PATIENT PAIN. THE ORIGINAL PROCEDURE WAS A BICEPS LOOP N TAK. SURGEON WAS ABLE TO CORRECT ISSUE WITH A 2.6 KNOTLESS FIBERTAK SUBPC. ONLAY.

  Patient problems: Pain

  MAUDE report 13928465 ↗
• InjuryAug 11, 2020Break

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A REVISION SHOULDER ARTHROSCOPY, REVISING A PREVIOUS LABRAL REPAIR BY CUTTING AND SHAVING OUT PREVIOUSLY IMPLANTED SUTURETAPE FIBERLINK. DURING THE PROCESS THE INNER BLADE PARTIALLY BROKE BUT IT IS STILL ATTACHED. THIS CAUSED THE OUTER BLADE TO BECOME NOTCHED AND THE SHAVER TO LOCK UP. THERE WAS NO RETAINED MATERIAL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A MORE AGGRESSIVE SHAVER (4.0 EXCALIBUR). ADDITIONAL INFORMATION OBTAINED 07/28/2020: THE PATIENT HAD A LABRAL REPAIR SURGERY SOMETIME IN (B)(6) 2019 TO REPAIR A BUFORD COMPLEX. THE REVISION WAS BEING PERFORMED DUE TO OVER TIGHTENING OF THE SHOULDER. THE SPECIFIC ARTHREX PRODUCT USED IN THE ORIGINAL PROCEDURE, THE ORIGINAL PROCEDURE SURGEON NAME AND FACILITY ARE ALL UNKNOWN AND HAVE NOT BEEN PROVIDED BY THE REVISING SURGEON. THE SPECIFIC PRODUCTS ORIGINAL IMPLANTED ARE NOT KNOWN. HOWEVER THE SALES REP WHO WAS PRESENT DURING THE REVISION STATES THE PART IS BELIEVED TO BE AR-7535. THE ANCHOR BODIES AND EYELET WERE NOT REMOVED DURING THE REVISION PROCEDURE. JUST THE SUTURETAPE FIBERLINK FROM THE ANCHORS WAS CUT AND SHAVED OUT. REPORTER STATES THE DEVICE DID NOT HIT BONE OR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393442 ↗