STRATAFIX SXPP1A422Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031245334), received between Feb 2, 2023 and Jul 8, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT UPON CUTTING THE SUTURES, THE SUTURE SPLIT IN HALF. NO ADVERSE IMPACT TO PATIENT/USER. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438014 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921735 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921152 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921145 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921142 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920438 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE SEVERAL STRANDS OF BARBED SUTURE BROKE OR SPLIT DURING THE PROCEDURE. ANOTHER LIKE DEVICE WAS OPENED TILL THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920423 ↗
• MalfunctionApr 18, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE SPLIT IN TWO AT NEEDLE TO FIRST BARB. LOOKS LIKE IT SPLIT INTO TWO. THIS HAPPENED AFTER A FEW PASSES. STANDARD HANDLING TECHNIQUE, NO EXTRA PULLING WAS MADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865006 ↗
• MalfunctionApr 18, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE SPLIT IN TWO AT NEEDLE TO FIRST BARB. LOOKS LIKE IT SPLIT INTO TWO. THIS HAPPENED AFTER A FEW PASSES. STANDARD HANDLING TECHNIQUE, NO EXTRA PULLING WAS MADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865005 ↗
• MalfunctionApr 18, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE SUTURE SPLIT IN TWO AT NEEDLE TO FIRST BARB. LOOKS LIKE IT SPLIT INTO TWO. THIS HAPPENED AFTER A FEW PASSES. STANDARD HANDLING TECHNIQUE, NO EXTRA PULLING WAS MADE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865004 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE SYMMETRIC SUTURE BROKE AT NEEDLE LEADER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864529 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT THE SYMMETRIC SUTURE BROKE AT NEEDLE LEADER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21864527 ↗
• MalfunctionDec 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF WHEN TYING THE TWO BACK STITCHES TRYING TO SECURE THEM. SHE WAS ABLE TO KEEP THE NEEDLES IN THE ROBOT ARM. THEY WERE ABLE TO COMPLETE THE CASE WITHOUT PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917013 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT WENT INTO SURGERY THREE WEEKS LATER AND ENDED UP HAVING SOME BLEEDING. THEY IDENTIFIED SHE HAD A VAGINAL CUFF DEHISCENCE AND THEY HAD TO GO BACK AND RESEW THE VAGINAL CUFF. THE SURGEON WAS NOT SURE WHAT THE REASON WAS FOR THE VAGINAL CUFF DEHISCENCE UNKNOWN OF THE CURRENT CONDITION OF PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 16287195 ↗