Arthrex® AR-7534TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867288867), received between Jun 11, 2024 and Jan 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break

  ON 16-DEC-2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-7534T TIGERLOOP EXPERIENCED AN ISSUE. AFTER THE GRAFT WAS SUTURED, THE TAPE BROKE. ALL SUTURE MATERIAL WAS RETRIEVED, AND THE SURGERY WAS COMPLETED USING THE PRODUCT AS INTENDED. NO SIGNIFICANT SURGERY DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 23-DEC-2025: THIS ISSUE OCCURRED WHILE THE AR-7534T TIGERLOOP WAS IN THE PATIENT. AFTER THE SUTURES BROKE, ONLY THE BROKEN FRAGMENTS WERE REMOVED, AS THE REMAINING PORTION STILL APPEARED TO CONTRIBUTE TO THE FIXATION OF THE TENDON.

  Patient problems: Foreign Body In Patient

  MAUDE report 23960586 ↗
• MalfunctionNov 24, 2025Break; Break

  ON (B)(6) 2025, AN EMPLOYEE FROM AN ARTHREX SUBSIDIARY REPORTED VIA EMAIL THAT AN AR-7534T TIGERLOOP EXPERIENCED A FAILURE. AFTER THE DEVICE WAS PASSED THROUGH THE BONE TUNNEL, ONE SIDE OF THE TAPE BROKE DURING EXTENSION AND FLEXION. THE SURGERY, AN ACL RECONSTRUCTION PERFORMED ON (B)(6) 2025, WAS COMPLETED USING ONLY THE TIGERLOOP WITHOUT THE USE OF ANY ADDITIONAL PRODUCTS. NO SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED, NO ADDITIONAL ANESTHESIA WAS ADMINISTERED, AND NO ADVERSE EFFECTS WERE OBSERVED IN THE PATIENT DURING OR FOLLOWING THE SURGERY AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/11/2025: THE BROKEN TAPES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632693 ↗
• MalfunctionMay 1, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 5/1/2025: THIS ISSUE OCCURRED WHILE IT WAS INSIDE THE PATIENT. ALL THE BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT ADMINISTERED.

  Patient problems: Insufficient Information

  MAUDE report 21942374 ↗
• MalfunctionJun 11, 2024Break; Break

  ON 2/9/2022 IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-7534T TIGERLOOP SUTURE TAPE LOOP AT THE END OF THE NEEDLE BROKE IMMEDIATELY AFTER SURGEON APPLIED TENSION. SURGEON USED A NEW PRODUCT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING AN PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 2/10/2022: THIS WAS DISCOVERED DURING AN ACL REPAIR PROCEDURE. THE LOOP OF THE NEEDLE BROKE OUTSIDE OF THE PATIENT'S BODY AND CASE WAS COMPLETED USING ANOTHER AR-7534T, LOT NUMBER IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19509882 ↗