Arthrex® AR-1588RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00888867019553), received between Oct 14, 2016 and Sep 8, 2026 — classified as 25 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Break” (56 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Inadequacy of Device Shape and/or Size

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667616 ↗
• MalfunctionJul 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50068601 ↗
• MalfunctionApr 14, 2026Break

  ON 26TH MARCH 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT, ACL TIGHTROPE® RT, THE SUTURE BROKE WHEN THE PRODUCT WAS BEING USED. THIS WAS DETECTED DURING USE IN A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE JOINT SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER NEW AR-1588RT WAS USED. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873410 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE SNAPPED UPON INSERTION INTO THE FEMORAL TUNNEL. 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 24829827 ↗
• MalfunctionMar 23, 2026Positioning Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE TIGHTROPE RT COULD NOT BE SHORTENED. THE GRAFT WAS WITHDRAWN FROM THE BONE CANAL. THE GRAFT WAS PULLED INTO THE CANAL WITHOUT THE TIGHTROPE SYSTEM AND FIXED FEMUR-SIDE WITH A SCREW. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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 24667768 ↗
• MalfunctionMar 23, 2026Break

  ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, ITS SUTURE BROKE. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662309 ↗
• MalfunctionMar 23, 2026Break

  ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, IT WAS BROKEN WHEN TIGHTENING THE SUTURE. THIS WAS DETECTED DURING A TENDON RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662101 ↗
• MalfunctionMar 23, 2026Break

  ON 3RD MARCH 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, IT WAS BROKEN WHEN TIGHTENING THE SUTURE. THIS WAS DETECTED DURING A TENDON RECONSTRUCTION SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661959 ↗
• MalfunctionMar 18, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SURGERY THE DEVICE TORE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED. UPDATE 02-MAR-2026: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED ISSUE OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY. 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 24632189 ↗
• MalfunctionFeb 10, 2026Break

  ON 21ST JAN 2026, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE WHITE SUTURE BROKE WHEN RETRIEVING THE IMPLANT. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2026. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303710 ↗
• InjuryJan 14, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE PATIENT SUFFERS FROM POOR WOUND HEALING WHICH LEADS TO BACTERIAL INFECTION. THIS WAS DETECTED AFTER AN ARTHROSCOPIC PLATE FIXATION SURGERY FOR TREATMENT WHICH HAPPENED ON (B)(6) 2025. THE BACTERIAL INFECTION OCCURRED ON (B)(6) 2025. THE PATIENT WAS READMITTED FOR TREATMENT. EXAMINATION REVEALED SUPERFICIAL STAPHYLOCOCCUS AUREUS 4+. THE ORIGINAL SURGERY COMPLETED, BUT ADDITIONAL DEBRIDEMENT SURGERY PERFORMED TO TREAT THE INFECTION. ADDITIONAL INFORMATION: TREATMENT INCLUDED SUBCUTANEOUS INJECTION OF ENOXAPARIN 3800 IU ONCE DAILY FOR ANTICOAGULATION, WOUND DRESSING CHANGES, INTRAVENOUS INFUSION OF VANCOMYCIN 1000 MG EVERY 12 HOURS FOR ANTI-INFECTION, AND DEBRIDEMENT SURGERY. BY DECEMBER 16, THE WOUND HAD HEALED WELL. RE-EXAMINATION SHOWED THAT INFLAMMATORY BLOOD MARKERS HAD RETURNED TO NORMAL, AND THE PATIENT WAS DISCHARGED. AFTER DISCHARGE, THE PATIENT NEEDS TO CONTINUE ORAL ANTIBIOTICS FOR 3 WEEKS, WITH LINEZOLID PRESCRIBED FOR ONGOING ANTI-INFECTION TREATMENT.

  Patient problems: Bacterial Infection; Impaired Healing

  MAUDE report 24066122 ↗
• MalfunctionDec 31, 2025Break; Break

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, BOTH UNITS OF THE SUTURE BROKE WHEN RETRIEVING. THIS WAS DETECTED DURING AN AUTOLOGOUS TENDON RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT THROUGH KNEE ARTHROSCOPY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW ONE. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934416 ↗
• MalfunctionDec 31, 2025Break; Break

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 2 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, BOTH UNITS OF THE SUTURE BROKE WHEN RETRIEVING. THIS WAS DETECTED DURING AN AUTOLOGOUS TENDON RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT THROUGH KNEE ARTHROSCOPY SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW ONE. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934324 ↗
• MalfunctionDec 16, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  IT WAS REPORTED THAT DURING THE KNEE SURGERY, THE BUTTON OF THE TIGHTROPE DID NOT FLIP AND IT WAS DIFFICULT TO TIGHTEN THE SUTURES. 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 23815582 ↗
• MalfunctionDec 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/19/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1588RT ACL TIGHTROPE LOOPS GOT STUCK. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED 12/9/2025: IT WAS FURTHER REPORTED THAT THIS WAS DISCOVERED DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE WHILE THE DEVICE WAS ADVANCING WITH THE GRAFT FROM THE TIBIAL TUNNEL TOWARD THE FEMORAL TUNNEL. THE CASE WAS COMPLETED WITH A NEW DEVICE AND THERE WAS NO DELAY IN SURGERY AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776911 ↗
• MalfunctionOct 24, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WHITE SUTURE TORE WHILE SHUTTLING. 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 23380725 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 1ST SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE SUTURE BROKE OFF SUDDENLY WHEN RETRIEVING THE IMPLANT. THIS WAS DETECTED DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23094785 ↗
• MalfunctionSep 18, 2025Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY IT WAS NOTICED THAT THE TIGHTROPE WAS INCORRECTLY ASSEMBLED AND NO EXTENSION OF THE LOOP WAS POSSIBLE. 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 23083902 ↗
• MalfunctionAug 22, 2025Break; Break

  ON 6TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, WHEN TIGHTENING THE WHITE SUTURE, IT BROKE. THIS WAS DETECTED DURING A REPAIR OF ANTERIOR CRUCIATE LIGAMENT INJURY OF THE KNEE JOINT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872950 ↗
• MalfunctionAug 21, 2025Difficult or Delayed Positioning; Use of Device Problem; Difficult or Delayed Positioning; Use of Device Problem

  ON 8/4/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-1588RT ACL TIGHTROPE RT DID NOT LOCK. AT THE END OF THE PROCEDURE, IT WAS NOTICED THAT THE GRAFT HAD SHIFTED. TO CORRECT THIS, ANOTHER SUSPENSION SYSTEM HAD TO BE IMPLANTED TO RAISE AND LOCK THE GRAFT AGAIN. THIS WAS DISCOVERED DURING AN ACLR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 08/14/2025: THE CASE WAS COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866399 ↗
• MalfunctionAug 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 29TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE WHITE SUTURE CANNOT PULL OUT. THIS WAS DETECTED DURING A TENDON RECONSTRUCTION SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1588RT. THERE IS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794872 ↗
• MalfunctionAug 11, 2025Positioning Failure; Positioning Failure

  ON 28TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1588RT, ACL TIGHTROPE® RT, THE IMPLANT CANNOT BE DEPLOY. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION OF THE KNEE JOINT ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER AR-1588RT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION: THIS CASE REPORTED BY HOSPITAL AS AE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774904 ↗
• MalfunctionJul 31, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 07/05/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1588RT ACL TIGHTROPE RT HAD A BLOCKED IMPLANT DURING USE. THERE WAS NO REPORT OF BREAKAGE DURING THIS PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER PRODUCT; NO FURTHER DETAILS WERE PROVIDED. THIS WAS DISCOVERED DURING AN LCA PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 07/11/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674677 ↗
• MalfunctionJul 29, 2025Break; Break

  ON 7TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT, ACL TIGHTROPE® RT, THE WHITE SUTURE BROKE WHEN RETRIEVING THE IMPLANT. THIS WAS DETECTED DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649925 ↗
• MalfunctionJul 29, 2025Break; Break

  ON 7TH JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1588RT, ACL TIGHTROPE® RT, THE WHITE SUTURE BROKE WHEN RETRIEVING IT. THIS WAS DETECTED DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT PROCEDURE 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649676 ↗