STRATAFIX SXPP1B453Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10705031240827), received between Jan 2, 2018 and Sep 29, 2026 — classified as 5 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Break” (54 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 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936021 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935927 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935810 ↗
• MalfunctionSep 29, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. The suture breaks more easily than usual. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935807 ↗
• MalfunctionSep 29, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. The suture breaks more easily than usual. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935780 ↗
• MalfunctionSep 29, 2026Break

  It was reported that a patient underwent an unknown procedure on an unknown date and barbed suture was used. The suture breaks more easily than usual. No adverse patient consequences were reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935757 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373186 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373181 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50331136 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164006 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163723 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. THE LOOP HAD BEEN MISSING WHEN THE PACKAGE OF THE NEWLY DISPENSED PRODUCT WAS JUST OPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163401 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163235 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163190 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT WHILE THE SURGEON WAS SUTURING MESH, IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE SUTURE. THE DETACHMENT OCCURRED DURING USE, AND THE SUTURE COULD NO LONGER BE UTILIZED AS INTENDED. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE FOR RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161978 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT WHILE THE SURGEON WAS SUTURING MESH, IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE SUTURE. THE DETACHMENT OCCURRED DURING USE, AND THE SUTURE COULD NO LONGER BE UTILIZED AS INTENDED. NO PATIENT CONSEQUENCES. DEVICE IS AVAILABLE FOR RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161972 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW PERITONEUM. 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 25044276 ↗
• InjuryMar 5, 2026Break

  IT WAS REPORTED BY A SALES REP THAT, DURING AN ORTHOPEDIC SURGERY AT THE WARDS/ICU, SXPP1B453 WAS USED FOR THE DERMIS IN A TRAUMATIC PELVIC CASE. (PRINEO WAS USED FOR THE EPIDERMIS.) AT THE OUTPATIENT VISIT AFTER SURGERY, DERMAL DEHISCENCE WAS CONFIRMED. THE PRODUCT WAS USED ON THE PELVIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. AFFILIATE REFERENCE NUMBER: (B)(4).

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24525078 ↗
• InjuryMar 5, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PRODUCT WAS USED ON THE SCAPULA. THE INCISION WAS A ¿V-SHAPED¿ (ANGLED) INCISION ALONG THE SCAPULA. TWO SUTURES WERE USED, ONE ON EACH SIDE. WOUND DEHISCENCE OCCURRED ON THE RIGHT SCAPULAR SIDE, WHEREAS NO DEHISCENCE OCCURRED ON THE LEFT SCAPULAR SIDE. THE DOCTOR POINTED OUT THAT THE POSSIBILITY OF A BURN ON THE RIGHT SHOULDER AND SUBCUTANEOUS DEGLOVING. SUTURE CONDITION: POSSIBILITY DUE TO PROGRESSING HYDROLYSIS, THE DISSOLVED SUTURE WAS NOT PURPLE BUT NEARLY TRANSPARENT. THE BROKEN SUTURE IS IN A CONDITION OF PROTRUDING LOOSELY FROM THE WOUND. AT AN OUTPATIENT VISIT, ADDITIONAL SUTURING WAS PERFORMED IN THE TREATMENT ROOM. THE PATIENT¿S CURRENT CONDITION IS STABLE, WITH NO INFECTION AFTER THE WOUND DEHISCENCE AND NO OTHER PARTICULAR ISSUES. DOCTOR¿S COMMENTS: THERE WAS A BURN ON THE RIGHT SHOULDER AND POSSIBLE SUBCUTANEOUS DEGLOVING, WHICH MAY HAVE MADE THE TISSUE FRAGILE AND CONTRIBUTED TO THE EVENT. DIFFERENT DOCTORS PERFORMED THE SUTURING ON THE RIGHT AND LEFT SIDES, AND DIFFERENCES IN TECHNIQUE MAY HAVE INFLUENCED THE OUTCOME. EXCESSIVE TENSION DURING SUTURING MIGHT

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 24525077 ↗
• MalfunctionDec 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN PROSTATECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23935325 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON REPORTED TO THE SALES REP THAT DURING A ROBOTIC VENTRAL HERNIA PROCEDURE, A SUTURE SNAPPED AND BROKE. A SECOND SUTURE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819108 ↗
• MalfunctionNov 26, 2025Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658360 ↗
• MalfunctionNov 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE PRODUCT WAS LABELED AS 22CM SO FAR, BUT THIS WAS LABELED AS 23CM. IS THERE ANY DIFFERENCE IN THE CONTENTS? IT IS UNKNOWN WHETHER THE CONTENT WAS DIFFERENT OR NOT. PLEASE SEE THE ATTACHED PHOTO FOR THE PACKAGE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO SAMPLE WILL BE RETURNED. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585722 ↗
• MalfunctionSep 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS LABELED AS 23CM IN THE CATALOG AND THE ALUMINUM PACKAGE IS ORIGINALLY LABELED AS 22CM BUT SOME ALUMINUM PACKAGES WERE LABELED AS 23CM. THERE WAS NO PROBLEM WITH THE PRODUCT DUE TO THE LABEL OF THE ALUMINUM PACKAGE. THIS EVENT WAS FOUND BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083484 ↗
• MalfunctionAug 25, 2025Positioning Failure; Defective Component; Positioning Failure; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. AT 06:25, THE DOCTOR USED THE SUTURE TO REPAIR THE DUODENAL PERFORATION FOR THE PATIENT WITH DUODENAL PERFORATION. AFTER TYING THE KNOT, THE KNOT WAS LOOSE. AFTER OPENING THE SUTURE PACKAGE, THE DOCTOR TOUCHED IT AND FOUND NO BARB. THE EFFECT OF SUTURE ON PERFORATION WAS OBSERVED DURING SUTURE. NO ABNORMALITY WAS FOUND AND CONTINUED TO USE IT. CLOSELY OBSERVE PATIENT'S WOUND CONDITION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885376 ↗