STRATAFIX SXPP1B418Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031235908), received between Oct 21, 2025 and Aug 17, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Structural Problem; Material Integrity Problem; Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280285 ↗
• MalfunctionAug 17, 2026Structural Problem; Material Integrity Problem; Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50280204 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT THE NEEDLE DETACHED 3 TIMES IN A ROW IN THE SAME BOX WITH THE SAME LOT NUMBER. THIS WAS DURING A PROCEDURE WHERE THE PATIENT WAS ON THE TABLE WHILE PASSING THROUGH THE TISSUE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348152 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT THE NEEDLE DETACHED 3 TIMES IN A ROW IN THE SAME BOX WITH THE SAME LOT NUMBER. THIS WAS DURING A PROCEDURE WHERE THE PATIENT WAS ON THE TABLE WHILE PASSING THROUGH THE TISSUE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348149 ↗
• MalfunctionOct 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT THE NEEDLE DETACHED 3 TIMES IN A ROW IN THE SAME BOX WITH THE SAME LOT NUMBER. THIS WAS DURING A PROCEDURE WHERE THE PATIENT WAS ON THE TABLE WHILE PASSING THROUGH THE TISSUE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348146 ↗