STRATAFIX SXMP1B449Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031470002), received between Oct 5, 2023 and Feb 24, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT DURING A PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON OBSERVED A SECTION OF THE SUTURE MATERIAL THAT APPEARED FRAYED, AS IF PART OF THE SUTURE WAS ¿SPITTING,¿ WITH NO PATIENT CONSEQUENCES NOTED; THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434842 ↗
• MalfunctionOct 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23227789 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATOBILIARY SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY AT THE SECOND STITCH. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036428 ↗
• MalfunctionMay 14, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE SUTURING OPERATION, THE TAIL END OF THE NEEDLE BROKE AND COULD NOT BE USED. IT WAS IMMEDIATELY REMOVED AND CHECKED FOR INTEGRITY, AND A NEW NEEDLE WAS REPLACED TO CONTINUE SUTURING. THIS EVENT HAS AFFECTED THE PATIENT'S SURGICAL PROGRESS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22017812 ↗
• 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 21784252 ↗
• InjuryApr 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS TRAILED. THE PATIENT EXPERIENCED A BLADDER LEAK FROM THE URETEROVESICAL ANASTOMOSIS. A LEAK TEST WAS CONDUCTED INTRA-OPERATIVELY, AND THE ANASTOMOSIS LOOKED GOOD AT THE TIME. DURING PATIENT FOLLOW-UP, A LEAK WAS DISCOVERED AND DETERMINED TO BE FROM THE BLADDER. SURGEON OPINES THAT THE STRATAFIX SLIPPED AND CAUSED THE ANASTOMOSIS TO FAIL. SURGEON STATES HE HAS NEVER HAD A BLADDER LEAK IN OVER 1000 CASES, AND THE ONLY CHANGED VARIABLE IN THIS SPECIFIC PATIENT WAS THE BARBED SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21740924 ↗
• InjuryApr 1, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC PROSTATECTOMY ON AN UNKNOWN DATE IN 2025 AND BARBED SUTURE WAS TRIALED. THE PATIENT EXPERIENCED A BLADDER LEAK FROM THE URETEROVESICAL ANASTOMOSIS. A LEAK TEST WAS CONDUCTED INTRA-OPERATIVELY, AND THE ANASTOMOSIS LOOKED GOOD AT THE TIME. DURING PATIENT FOLLOW-UP, A LEAK WAS DISCOVERED AND DETERMINED TO BE FROM THE BLADDER. SURGEON OPINES THAT THE STRATAFIX SLIPPED AND CAUSED THE ANASTOMOSIS TO FAIL. SURGEON STATES HE HAS NEVER HAD A BLADDER LEAK IN OVER 1000 CASES, AND THE ONLY CHANGED VARIABLE IN THIS SPECIFIC PATIENT WAS THE BARBED SUTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 21740896 ↗
• 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 17877630 ↗