STRATAFIX SXPP1B419Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031235915), received between Oct 21, 2020 and Aug 12, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222487 ↗
• InjuryJul 30, 2026Positioning Failure

  It was reported that a patient underwent an unknown robotic urological procedure on an unknown date and a barbed suture was used. Post-op, the patient had to go back to the OR twice as closing with the suture, the same broke loose and created a fistula (Dehiscence). Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50091257 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. AFFECTS PATIENT SURGICAL SAFETY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461814 ↗
• MalfunctionDec 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933701 ↗
• MalfunctionNov 24, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED WITH HOLE PRIOR TO USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634194 ↗
• MalfunctionSep 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGICAL 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 22951086 ↗
• MalfunctionJan 9, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE HOSPITAL WAS REVIEWING PRODUCT IN STERILE CORE ON (B)(6) 2024 OF BARBED SUTURE. NOTED THAT THERE WERE TWO BOXES OF BARBED SUTURE. ONE BOX WAS NOTABLY LARGER THAN THE OTHER AND HAD DIFFERENT BRANDING ON THE BOX WHICH WAS INCONSISTENT WITH THAT PRODUCT CODE. BOX WAS STILL SEALED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118144 ↗
• MalfunctionMay 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FELL INTO THE PATIENT . THE LOT OF IP IS UNAVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352438 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT SINGLE HOLE THORACOSCOPY SURGERY ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE LOOP BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372373 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS A REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LOOP BROKE IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370798 ↗
• MalfunctionMar 9, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE IN 2021 AND THE BARBED SUTURE WAS USED. DURING SURGERY, ANASTOMOSIS HAD TO BE REPAIR BECAUSE OF GRIP DEFICIENCY OF THE BARBED SUTURE. THE PROCEDURE TIME WAS EXTENDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445984 ↗
• MalfunctionMar 9, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ANASTOMOSIS PROCEDURE IN 2021 AND THE BARBED SUTURE WAS USED. DURING SURGERY, ANASTOMOSIS HAD TO BE REPAIR BECAUSE OF GRIP DEFICIENCY OF THE BARBED SUTURE. THE PROCEDURE TIME WAS EXTENDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445973 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2020 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE CHEST, THE SUTURE BROKE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712850 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2020, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE CHEST, THE SUTURE BROKE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712847 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2020 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE CHEST, THE SUTURE BROKE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712846 ↗
• MalfunctionOct 21, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2020 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN CLOSING THE CHEST, THE SUTURE BROKE. THE LOT NUMBER IS UNKNOWN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10712844 ↗