STRATAFIX SXMP1B408Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031236356), received between Jun 19, 2018 and Apr 21, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (3 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.

• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DECUBITUS REMOVAL PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED COLIC PERFORATION ON THE 12TH DAY POST-OP. THE PATIENT UNDERWENT A NEW SURGERY WITH RESECTION OF THE INTERESTED PART. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Perforation

  MAUDE report 21873492 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON USED SUTURE TO SUTURE UTERUS AFTER REMOVING MIOMA. THE SUTURE BROKE OFF AS HE PULLED IT THROUGH THE LOOP. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21253193 ↗
• MalfunctionJul 18, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLON SURGICAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS NOT BARBED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699186 ↗
• MalfunctionJul 18, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLON SURGICAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS NOT BARBED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699185 ↗
• MalfunctionJul 18, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A COLON SURGICAL PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE WAS NOT BARBED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699176 ↗
• MalfunctionJun 19, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT HOLDING. THE SUTURE APPEARS TO NOT HAVE ANY BARBS ON IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7615724 ↗
• MalfunctionJun 19, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT HOLDING. THE SUTURE APPEARS TO NOT HAVE ANY BARBS ON IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614749 ↗
• MalfunctionJun 19, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS NOT HOLDING. THE SUTURE APPEARS TO NOT HAVE ANY BARBS ON IT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7614734 ↗