STRATAFIX SXMP1B445Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031470071), received between Nov 15, 2024 and Jul 3, 2025 — classified as 3 injuries, 1 malfunction.

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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DOCTOR HEARD FROM A COLLEAGUE THAT THEY WERE HAVING ISSUES WITH IT BEING USED ON THE VAGINAL CUSP AND DISCONTINUED USING. NO ADVERSE IMPACT TO PATIENT/USER. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22394150 ↗
• InjuryJul 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT A DOCTOR HEARD FROM A COLLEAGUE THAT THEY WERE HAVING ISSUES WITH IT BEING USED ON THE VAGINAL CUSP AND DISCONTINUED USING. NO ADVERSE IMPACT TO PATIENT/USER. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22394148 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. 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 22285977 ↗
• 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 20693854 ↗