STRATAFIX SXPP1B456Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10705031240872), received between Nov 13, 2018 and Sep 24, 2026 — classified as 3 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Break” (50 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 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. While suturing on valt closure, the suture broke. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888985 ↗
• MalfunctionAug 4, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131912 ↗
• MalfunctionAug 4, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131910 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633917 ↗
• MalfunctionJun 26, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633907 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954517 ↗
• MalfunctionMar 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 2 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ACCORDING TO SALE REP'S FEEDBACK, THIS HOSPITAL ADOPTS THE REGULAR VISITING PROCESS, THE SPECIFIC OPERATION TIME AND OPERATOR IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662447 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512133 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512064 ↗
• MalfunctionMar 4, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT UPON UNPACKING, A BLACK STAIN WAS FOUND ON THE NEEDLE BODY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506018 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL DOME. THE SURGEON DESCRIBED THAT THE BARBED SUTURE LACERATED THE VAGINAL DOME LEADING TO REAPPROACH ON (B)(6) 2025. THE PATIENT IS ALIVE AND WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 24161115 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL DOME. THE SURGEON DESCRIBED THAT THE BARBED SUTURE LACERATED THE VAGINAL DOME LEADING TO REAPPROACH ON (B)(6) 2025. THE PATIENT IS ALIVE AND WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 24161105 ↗
• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC GYNECOLOGICAL PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL DOME. THE SURGEON DESCRIBED THAT THE BARBED SUTURE LACERATED THE VAGINAL DOME LEADING TO REAPPROACH ON (B)(6) 2025. THE PATIENT IS ALIVE AND WELL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Laceration(s)

  MAUDE report 24161102 ↗
• MalfunctionJan 22, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATEAND SUTURE WAS USED. WHILE USING STRATAFIX, GOT FRAYED/TEAR OFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147096 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. WHEN THE INTERNAL ORGANS WERE SUTURED, THE SUTURE WAS BROKEN WITH A SLIGHT PULL, RESULTING IN A SMALL AMOUNT OF BLEEDING. RETURN TO THE SUPPLIER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23974201 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE LOOP HAD BROKEN OFF AND IT WENT TO SUTURE. NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT RETURNING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854115 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE LOOP HAD BROKEN OFF AND IT WENT TO SUTURE. NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT RETURNING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850195 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. THE LOOP HAD BROKEN OFF AND IT WENT TO SUTURE. NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT RETURNING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850138 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PRESENTED LAXITY AND WAS RELEASED BY REGRESSION, EVEN AFTER THE GUIDED TECHNIQUE WAS PERFORMED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294394 ↗
• MalfunctionOct 15, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO SALES REP BY THE SURGEON THAT DURING A ROBOTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON INSERTED THE NEEDLE INTO THE TROCAR, AND IT BENT. WHEN PULLING THE SECOND STITCH, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED USING VLOC SUTURES. THE DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286075 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN 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. UPON INVESTIGATING THE SAMPLE, A SHORT INSERTION WAS OBSERVED AT THE END OF THE SUTURE. VISUAL INSPECTION CONCLUDED THAT THE NEEDLE AND SUTURE WERE DETACHED, AS THE INSERTION END OF THE SUTURE DID NOT MEET THE SPECIFIED REQUIREMENTS. 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 23278929 ↗
• MalfunctionSep 5, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY+BILATERAL OOPHORECTOMY AND SALPINGECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, AT 15:33, THE PATIENT UNDERWENT SURGERY. WHEN THE DOCTOR USED SUTURE TO SUTURE THE CERVICAL STUMP, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, RESULTING IN INCOMPLETE SUTURING OF THE STUMP. THE DOCTOR THEN ADDED MORE SUTURES TO ENSURE PROPER SUTURING. BUT IF IT IS DURING THE SUTURING OF CRITICAL AREAS OR HEMOSTASIS SUTURING, IT MAY CAUSE DAMAGE TO THE PATIENT'S BLEEDING AND POSE CERTAIN RISKS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22984234 ↗
• MalfunctionAug 14, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806670 ↗
• MalfunctionAug 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED A NEEDLE APPEARANCE ISSUE. UPON OPENING THE PACKAGE, IT WAS DISCOVERED THAT THE NEEDLE HAD BLACK DOTS AND DEPRESSIONS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805254 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING THE OPERATION, AFFECTING THE OPERATION. RETURNED TO THE SUP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22741774 ↗