Arthrex® AR-1588RT-JRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00888867095533), received between Jan 10, 2018 and Sep 25, 2026 — classified as 8 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Protrusion/Extrusion

  On 11 Sep 2026, it was reported by an Arthrex employee via email that an AR-1588RT-J ACL TIGHTROPE RT W/ DEPLOYING SUTURE's suture failed. Upon inserting the graft and confirming the button flip, the ITB was found to be protruding. An additional incision was made and pushed back into place using an instrument such as a Pean clamp. Subsequently, the tensioning suture failed during the adjustment phase; however, since approximately 10 cm of the suture remained, adjustment was still possibleThe procedure was completed successfully using the same product. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898732 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50454656 ↗
• MalfunctionFeb 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURES OF THE DEVICE TORE. 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 24378232 ↗
• MalfunctionDec 1, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED DURING THE CRUCIATE LIGAMENT RECONSTRUCTION THAT THE SUTURE OF THE TIGHTROPE TORE WHEN THE GRAFT WAS BEING INSERTED, AND AS A RESULT, THE GRAFT HAD TO BE REMOVED. 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 23681509 ↗
• MalfunctionOct 20, 2025Use of Device Problem; Use of Device Problem

  ON 10/03/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT-J ACL TIGHTROPE RT EXPERIENCED AN ISSUE WHEN THE SURGEON TRIED TO SHRINK THE LOOP; IT DID NOT SHRINK. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-1588RT-J ACL TIGHTROPE RT. THERE WAS NO DETAILED INFORMATION ON THE TYPE OF SURGERY. THERE WAS NO SIGNIFICANT DELAY, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE REPORTED. NO PHOTOS WERE TAKEN OF THE EVENT. THE EVENT OCCURRED DURING A PROCEDURE ON (B)(6) 2025, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335500 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN INSERTING THE DEVICE THROUGH THE CHANNEL, THE SUTURES TORE. 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 22956202 ↗
• MalfunctionAug 27, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE WHITE SUTURE COULD NOT BE PULL OUT. THIS WAS DETECTED DURING A TENDON RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907110 ↗
• MalfunctionJul 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURES OF THE DEVICE TORE DURING IMPLANT INSERTION. 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 22542174 ↗
• MalfunctionApr 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE BUTTON DID NOT FLIP AND THE DEVICE DID NOT HOLD. 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 21858139 ↗
• MalfunctionNov 20, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE DEVICE TORE CLOSE TO THE BUTTON. 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 20735617 ↗
• MalfunctionSep 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE OF THE TIGHTROPE TORE OFF DURING TIBIAL RETRACTION OF THE DEVICE. THE SUTURETAPE WAS THEN INSERTED WITH A SCORPION DEVICE AND REATTACHED USING A SCREW AND A BUTTON. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY BY CHANGING THE FIXATION. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212657 ↗
• MalfunctionAug 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE WHITE SHUTTLE SUTURE OF THE DEVICE TORE DURING THE FEMORAL RETRACTION. THE TIGHTROPE COULD NO LONGER BE USED. 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 20051424 ↗
• MalfunctionAug 9, 2024Break; Break

  ON 8/1/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AR-1588RT-J ACL TIGHTROPE RT SUTURES BROKE WHEN PULLING THE GRAFT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-1588RT-J ACL TIGHTROPE RT. ADDITIONAL INFORMATION RECEIVED ON 8/5/2024: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE. THE CORRECT SURGERY DATE IS (B)(6) 2024. THE SUTURES BROKE INSIDE THE PATIENT. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NECESSARY. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19950624 ↗
• MalfunctionJul 24, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA AR-1588RT-J ACL TIGHTROPE RT SUTURES BROKE, AND THE GRAFT BECAME LOOSE. THE SUTURE CAME OFF THE CHINESE FINGER TRAP. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/8/2024: THIS WAS DISCOVERED DURING AN ACLR PROCEDURE. THIS OCCURRED WHEN THE GRAFT WAS BEING IMPLANTED. THE CASE WAS COMPLETED USING A NEW AR-1588RT-J ACL TIGHTROPE RT. THE CASE WAS BRIEFLY DELAYED; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819448 ↗
• InjuryJul 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DEVICE FAILED ON THE FEMORAL SIDE, A FEW MONTHS AFTER A HAMSTRING ANTERIOR CRUCIATE LIGAMENT SURGERY WAS DONE ON THE PATIENT. THE PATIENT HAS BEEN WALKING DOWN THE STAIRS AND FELL, AND THE PATIENT HAD INSTABILITY FOLLOWING THIS. THERE WAS NO VISIBLE DAMAGE TO THE TIGHTROPE LOOP; IT APPEARED INTACT. HOWEVER, THE LOOP SEEMS TO HAVE FAILED, RESULTING IN LAXITY OF THE ACL GRAFT AND ITS DISPLACEMENT FROM THE FEMORAL TUNNEL. A REVISION SURGERY WAS PERFORMED ON THE PATIENT, DURING WHICH ARTHROSCOPIC IMAGES CONFIRMED THE LOOP'S INTEGRITY. SUBSEQUENTLY, A BONE-PATELLAR TENDON-BONE (BTB) RECONSTRUCTION WAS CARRIED OUT ON JUNE 3RD 2024 AS A REVISION PROCEDURE. X- RAYS HAVE ALSO BEEN TAKEN TO SHOW THE BUTTON IS CLEARLY IN THE CORRECT POSITION ON THE FEMORAL SIDE, AND HAS NOT MOVED INSIDE THE TUNNEL.

  Patient problems: Failure of Implant

  MAUDE report 19654610 ↗
• MalfunctionJun 20, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE WHITE SUTURE OF THE DEVICE TORE. 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. (B)(6) 2023 UPDATE DW FURTHER INFORMATION WERE PROVIDED THAT THE TORN PIECES WERE RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574706 ↗
• MalfunctionJun 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SUTURE BROKE WHILE TIGHTENING THE LOOP DURING IMPLANT INSERTION. 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 19562769 ↗
• MalfunctionJun 6, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT GRAFT LINK SURGERY DURING THE INSERTION OF THE GRAFT, THE TIGTROPE SUTURES OF THE DEVICE TORE. THEREFORE, THE GRAFT HAD TO BE COMPLETELY CREATED FROM THE START. 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 19477241 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED WHEN IMPLANTING THE AR-1588RT-J ACL TIGHTROPE RT ONE OF THE CINCHING SUTURES TORE FROM THE LOCKING MECHANISM. ANOTHER TIGHTROPE WAS OPENED AND USED TO COMPLETE THE CASE SUCCESSFULLY. SEE SOURCE DATA ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446056 ↗
• MalfunctionMay 27, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE LOOP OF THE TIGHT-ROPE WAS ALREADY RETRACTED IN THE PACKAGE. 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. UPDATE AVOE 28-MAR-2023 IT WAS CONFIRMED THAT THE DEVICE WAS USED ON THE PATIENT AND TORE WHEN THE LOOP OF THE TIGHT ROPE WAS ALREADY HALF CLOSED. ALL PARTS WERE RETRIEVED AND A NEW DEVICE WITH THE SAME PART NUMBER WAS USED TO FINISH THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400405 ↗
• MalfunctionMay 8, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE COULD NOT BE TIGHTENED. 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 19267679 ↗
• MalfunctionApr 4, 2024Break; Break

  ON 3/25/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1588RT-J ACL TIGHTROPE HAD AN ISSUE WHEN IMPLANTING. THE GRAFT WENT UP IN THE FEMORAL TUNNEL BUT WHILE TRYING TO TENSION THE MECHANISM, THE SUTURE BROKE AND, THEREFORE; THE IMPLANT WAS UNUSABLE.

  Patient problems: Insufficient Information

  MAUDE report 19040998 ↗
• MalfunctionApr 4, 2024Break; Break

  ON 3/25/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1588RT-J ACL TIGHTROPE RT SUTURES BROKE WHEN TENSIONING THE MECHANISM. THIS WAS DISCOVERED DURING A PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19040947 ↗
• MalfunctionMar 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHITE SUTURE OF THE DEVICE TORE COMPLETELY DURING INSERTION OF THE DEVICE. 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 18858164 ↗
• MalfunctionDec 26, 2023Positioning Failure; Loose or Intermittent Connection; Positioning Failure; Loose or Intermittent Connection

  ON 11/28/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1588RT-J ACL TIGHTROPE RT WOULD NOT TENSION. AFTER THE GRAFT WAS IMPLANTED, THE TIBIAL FIXATION AND TENSIONING WERE LOOSE AND AFTER SEVERAL PULLS, THE GRAFT FELL OFF. IT WAS CONFIRMED THAT THE GRAFT DID NOT TEAR, SO ANOTHER AR-1588RT-J WAS USED TO COMPLETE FIXATION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023

  Patient problems: Insufficient Information

  MAUDE report 18394179 ↗