STRATAFIX SXMP1B415Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031236431), received between Apr 7, 2023 and Mar 31, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A LEAK FROM THE BLADDER ANASTOMOSIS. IT IS UNKNOWN WHAT INTERVENTION WAS DONE, IF OVER SEWING WAS DONE OR A FOLLOW UP SURGERY. THE PATIENT IS FINE AND THE SUTURE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21730139 ↗
• InjuryApr 7, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE IN EARLY (B)(6) 2023 AND BARBED SUTURE WAS USED ON THE VAGINAL CUFF. TWO AND HAFF WEEKS LATER, THE PATIENT STARTED PASSING BLOOD CLOTS. THEY REOPERATED AT THREE WEEKS AND FOUND THAT THE SUTURE HAD COMPLETED DEHISCENCE AT THE VAGINAL CUFF. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Wound Dehiscence

  MAUDE report 16701090 ↗