STRATAFIX SXMP1B452Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031470095), received between Jan 26, 2024 and Sep 23, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872771 ↗
• MalfunctionSep 1, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543057 ↗
• MalfunctionJun 25, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623089 ↗
• MalfunctionJun 19, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPIC EXTENSIVE HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY (SXMP1B452/109AGU. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY (SXPP1A405/10ABD4, AND THE FIXATION FEATURE WAS FOUND DETACHED DURING SURGERY. BESIDES, THE SUTURE BROKE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25563423 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428215 ↗
• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25428155 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330088 ↗
• MalfunctionMay 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280920 ↗
• MalfunctionMay 12, 2026Device Markings/Labelling Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE BARBED SUTURE PACKAGES DO NOT LOOK THE SAME. THEY¿RE MISSING INFORMATION AND THE CUSTOMER IS WONDERING WHY SOME SYMBOLS ARE NOT ON THE OUTER AND INNER PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148545 ↗
• MalfunctionMay 11, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25141665 ↗
• MalfunctionDec 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819030 ↗
• MalfunctionSep 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, AT 11:50 ON THE SAME DAY, THE SUTURE WAS OPENED AND TAKEN TO THE OPERATING TABLE BY THE INSTRUMENT NURSE FOR USE. WHEN THE SURGEON PLACED THE SUTURE INTO THE ABDOMINAL CAVITY TO PREPARE FOR SUTURING, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED. THE NEEDLE AND SUTURE WERE IMMEDIATELY REMOVED AND A NEW SUTURE WAS USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23158638 ↗
• MalfunctionSep 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23077009 ↗
• MalfunctionSep 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. DURING THE INITIAL INSPECTION OF THE SAMPLE, HOLES WERE OBSERVED IN THE TOP FOIL PACKET, SUGGESTING IT WAS CAUSED FROM THE OUTSIDE IN BY AN UNKNOWN OBJECT COMPROMISING THE INTEGRITY OF THE STERILITY. ADDITIONALLY, A PHOTOGRAPH WAS PROVIDED, CLEARLY DISPLAYING THE DAMAGED PACKAGING, WHICH IS CONSISTENT WITH THE CONDITION OF THE RECEIVED SAMPLE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967567 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OVARIAN CYST REMOVAL PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE AT THE FIRST STITCH. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097319 ↗
• MalfunctionMay 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. WHILE SUTURING PERITONEUM THE NEEDLE FELL OFF OF THE SUTURE. PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976856 ↗
• MalfunctionApr 23, 2025Material Frayed; Material Frayed

  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 THE SALES REP THAT THE SUTURE FRAYED IN SURGERY. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894390 ↗
• InjuryNov 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SCALP TUMOR RESECTION SURGERY ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED INFLAMMATION AND AN ABSORPTION ISSUE. WITHIN ONE MONTH AFTER SURGERY, THE WOUND REPEATEDLY DEVELOPED PUS AND REDNESS, WHICH WAS DIAGNOSED WITH INFLAMMATION CAUSED BY NONE ABSORPTION OF SUTURE ACCORDING TO THE PATIENT. THE WOUND HAD BEEN CLEARED MULTIPLE TIMES IN THE HOSPITAL. UNTIL 45 DAYS AFTER SURGERY, THE WOUND HAD NOT HEALED, AND THE CONDITION HAS WORSENED, WITH SEVERE REDNESS, SWELLING, PUS, ITCHING, AND UNBEARABLE PAIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Impaired Healing; Inflammation; Itching Sensation; Pain; Purulent Discharge; Skin Inflammation/ Irritation

  MAUDE report 20693855 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT OF PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18959001 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON MENTIONED HE HAD TWO SUTURE NEEDLES IN A ROW POP OFF DURING A CASE LATE LAST YEAR. HE WAS ABLE TO USE A DIFFERENT SUTURE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE AND THEY DID NOT KEEP THE STRANDS OF SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697210 ↗
• MalfunctionFeb 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON MENTIONED HE HAD TWO SUTURE NEEDLES IN A ROW POP OFF DURING A CASE LATE LAST YEAR. HE WAS ABLE TO USE A DIFFERENT SUTURE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE AND THEY DID NOT KEEP THE STRANDS OF SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697152 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES WERE BREAKING AT THE SWAGE. THE DOCTOR WAS DOING A ROBOTIC VENTRAL HERNIA REPAIR. THEY ARE SENDING BACK TWO OF THE SAME LOT NUMBER FOR ANALYSIS. THE ACTUAL SUTURE THAT BROKE WAS DISCARDED. PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588979 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, MULTIPLE SUTURES WERE BREAKING AT THE SWAGE. THE DOCTOR WAS DOING A ROBOTIC VENTRAL HERNIA REPAIR. THEY ARE SENDING BACK TWO OF THE SAME LOT NUMBER FOR ANALYSIS. THE ACTUAL SUTURE THAT BROKE WAS DISCARDED. PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588879 ↗