STRATAFIX SXMP1B424Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031236509), received between May 13, 2019 and May 26, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE VESICOURETHRAL ANASTOMOSIS DURING A ROBOTIC CYSTECTOMY. SINCE THE BARBS WERE NOT ENGAGING ADEQUATELY WITH THE TISSUE, THE TISSUE WAS SLIPPING AND THE DEVICE COULD NOT BE USED AS INTENDED. PROCEDURE WAS DELAYED BY 5 MINUTES. UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25281761 ↗
• MalfunctionMay 26, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PROSTATECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE VESICOURETHRAL ANASTOMOSIS DURING A ROBOTIC CYSTECTOMY. SINCE THE BARBS WERE NOT ENGAGING ADEQUATELY WITH THE TISSUE, THE TISSUE WAS SLIPPING AND THE DEVICE COULD NOT BE USED AS INTENDED. PROCEDURE WAS DELAYED BY 5 MINUTES. UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES DUE TO THE REPORTED EVENT. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25281760 ↗
• MalfunctionMay 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY SALES REP THAT DURING USE, THE NEEDLE AND THREAD ARE SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150942 ↗
• MalfunctionFeb 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHILE SUTURING, THE SUTURE AND NEEDLE WAS DETACH. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456416 ↗
• MalfunctionJun 13, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE WIRE WAS UNSTRIPPED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201790 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON STATED THAT THE PATIENT HAD A LEAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Kidney or Urinary Problem

  MAUDE report 22196301 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON STATED THAT THE PATIENT HAD A LEAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Kidney or Urinary Problem

  MAUDE report 22196294 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON STATED THAT THE PATIENT HAD A LEAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Kidney or Urinary Problem

  MAUDE report 22196290 ↗
• InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON STATED THAT THE PATIENT HAD A LEAK. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Unspecified Kidney or Urinary Problem

  MAUDE report 22196283 ↗
• MalfunctionJun 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING A RADICAL PROSTATECTOMY PROCEDURE THAT AFTER SUTURING THE URETHRAL ANASTOMOSIS A LEAK TEST WAS DONE AND A LEAK WAS FOUND. SURGEON OVER SEWED THE ANASTOMOSIS WITH A DIFFERENT SUTURE CODE. ANOTHER LEAK TEST WAS DONE AND NO LEAKS WERE FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO DEVICE RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 22144618 ↗
• InjuryApr 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. POST-OP, THE SUTURE CAME APART CAUSING A LEAK. THE PATIENT WAS READMITTED. THE PATIENT WAS OVER SEWED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21784256 ↗
• InjuryMar 25, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC J-TUBE PLACEMENT PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE IN HALF. THE SURGEON USED AN X-RAY TO LOCATE THE NEEDLE THAT FELL INTO THE LIVER BED. THE NEEDLE WAS RETRIEVED FROM PATIENT. THE PATIENT WAS HAVING POST-OP ISSUES AND THE SURGEON RE-DID THE J-TUBE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18975880 ↗
• MalfunctionJan 16, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, AND BARBED SUTURE WAS USED. AS SOON AS THE SURGEON HELD THE NEEDLE, THE NEEDLE AND THE SUTURE WERE SEPARATED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519812 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPOTED A PATIENT UNDERWENT AN DAVINCI PROCEDURE ON AN UNKNOWN DATE IN 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18016229 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL ROBOTIC PROSTATECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED ON THE ANASTOMOSIS. IT WAS STATED THAT ALL LOOKED GOOD IN THE PROCEDURE. POST-OP, THE PATIENT¿S ANASTOMOSIS DID NOT HEAL WELL AND DID NOT CLOSE. THE PATIENT IS BEING SENT TO ANOTHER FACILITY TO GET A RECONSTRUCTION. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS WAITING FOR A RECONSTRUCTION SURGERY. THE PATIENT ALSO HAS OTHER ISSUES UNRELATED TO THE ANASTOMOSIS. THE SURGEON WAS NOT SURE IF IT WAS FROM THE BARBED SUTURE OR IT WAS BECAUSE THE PATIENT HAS OTHER ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Impaired Healing

  MAUDE report 17877623 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSORAL THYROIDECTOMY ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BODY BROKE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14163968 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE NEAR THE ATTACHMENT AREA. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NEW SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8603824 ↗