Arthrex® AR-8701Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867044722), received between Oct 17, 2022 and May 22, 2024 — classified as 7 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 22, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 03/31/2023 BY A ARTHREX EMPLOYEE VIA (B)(4) THAT AN AR-8701 MICRO SUTURE LASSO WIRE DID NOT ADVANCE WHILE CHECKING THE WIRE LOOP OPERATION. USED A NEW PRODUCT AND THE CASE IS COMPLETED. NO PATIENT HARMS. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373107 ↗
• MalfunctionMay 7, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) THAT TWO AR-8701 SUTURELASSOS WIRES BROKE WHEN PULLING THE THREAD. THIS CASE WAS COMPLETED WITH A NEW PRODUCT OF THE SAME CATALOG NUMBER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262306 ↗
• MalfunctionMay 7, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS (B)(4) THAT TWO AR-8701 SUTURELASSOS WIRES BROKE WHEN PULLING THE THREAD. THIS CASE WAS COMPLETED WITH A NEW PRODUCT OF THE SAME CATALOG NUMBER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262259 ↗
• MalfunctionNov 9, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-8701 MICRO SUTURELASSOS WIRE WAS STUCK IN THE SHAFT. THIS OCCURRED DURING A LATERAL ANKLE LIGAMENT REPAIR ON (B)(6) 2023; ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 18103713 ↗
• MalfunctionNov 9, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) /2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA SEMS-(B)(4) THAT AN AR-8701 MICRO SUTURELASSO, SMALL CURVE HAD AN ISSUE. THE WIRE LOOP WAS STUCK. THE CASE WAS COMPLETED USING A NEW PRODUCT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 10/19/2023: THIS WAS DISCOVERED DURING A MENISCAL RECONSTRUCTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100821 ↗
• MalfunctionAug 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-8701 MICRO SUTURELASSOS WIRE IS NOT COMING OUT & IT IS GETTING STUCK. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652330 ↗
• MalfunctionOct 17, 2022Break; Difficult to Remove

  ON 10/5/2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-8701 MICRO SUTURE LASSO LOOPED WIRE BROKE WHILE TRYING TO REMOVE IT WITH A GRASPER. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615524 ↗