STRATAFIX SXPP1A442Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031244979), received between Jun 10, 2021 and Feb 20, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY CESAREAN SECTION ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE FASCIA. FIVE DAYS POST-OPERATION, THE SUTURE MATERIAL HAD PARTIALLY BROKEN DOWN IN THE MIDDLE, RESULTING IN WOUND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24405656 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. POST OPERATIVELY, WOUND DEHISCENCE OCCURRED WHICH REQUIRED THE PATIENT TO RETURN TO SURGERY. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15436925 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. POST OPERATIVELY, WOUND DEHISCENCE OCCURRED WHICH REQUIRED THE PATIENT TO RETURN TO SURGERY. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15436919 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. ON (B)(6) 2022, WOUND DEHISCENCE OCCURRED WHICH REQUIRED THE PATIENT TO RETURN TO SURGERY. THE DEVICE IS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15436915 ↗
• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY ON (B)(6) 2021 AND SUTURE WAS USED. A MONTH LATER, THE PATIENT RETURNED FOR AN EX-LAP/BOWEL RESECTION AND A SMALL BOWEL ADHESION WAS FOUND. THE PHYSICIAN OPINED THE BARBS WERE THE CAUSE OF THE SMALL BOWEL ADHESION WHICH RESULTED IN THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Adhesion(s)

  MAUDE report 11979230 ↗