STRATAFIX SXMP1B444Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031470064), received between Jun 14, 2024 and Nov 14, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THERE WAS AN INTERMITTENT BLEEDING AND VAGINAL CUFF SEPARATION. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 23553164 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR VAGINAL CUFF REPAIR. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Wound Dehiscence

  MAUDE report 23553163 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED TO OVERSEE THE SEPARATION OF THE VAGINAL CUFF. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23553161 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. EIGHT WEEKS POST-OP, THERE WAS VAGINAL CUFF DEHISCENCE WITH FLUID LEAKAGE. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 23553160 ↗
• MalfunctionJun 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT ROBOTIC MYOMECTOMY, THE NEEDLE CAME OFF. THIS WAS SEVERAL MONTHS AGO THEY COULD NOT RECALL. NO PATIENT HARM WAS REPORTED. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150883 ↗
• MalfunctionMar 26, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON IT WAS OBSERVED DURING A CASE AFTER THE STRATAFIX WAS INTRODUCED INTO THE ABDOMEN, THE LOOP WAS BROKEN. THE SUTURE WAS REMOVED AND A NEW ONE WAS INTRODUCED. THE PROCEDURE WAS DELAYED BY THREE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698749 ↗
• InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT PROCEDURE ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. ONE WEEK POST-OP OF A GASTRIC NERUOSTIMULATOR IMPLANT WITH A PILORAPLASTY, THE PATIENT UNDERWENT A NEURO STIMULATOR REMOVAL. BOTH THOSE CASES WERE ROBOTIC. THE PATIENT RETURNED FOR A GASTRIC LEAK. FOUR LEAK TESTS WERE PERFORMED. THEY CONFIRMED THERE WAS A GASTRIC LEAK BUT WERE UNABLE TO CONFIRM WHERE THE LEAK WAS OCCURRING FROM. THE PATIENT WAS SENT TO GI TO GET A STINT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19585177 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP BROKE WHEN THE SURGEON TRIED TO TUG UP ON THE SUTURE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19535733 ↗