STRATAFIX SXPP1B408Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031236110), received between Apr 27, 2018 and Apr 30, 2026 — classified as 3 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Positioning Failure; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING A CAESAREAN SECTION FOR UTERINE SUTURING, THE DOCTOR NOTICED THAT THE BARB SEEMED LESS THAN USUAL AND USE WAS STOPPED AFTER SUTURING THE FIRST LAYER. THE BARB WAS COMPLETELY INEFFECTIVE, AND THE AREA THAT HAD BEEN SUTURED UP TO THAT POINT CAME UNDONE WHEN THE SUTURE WAS STOPPED MIDWAY AND THE SUTURE WAS CUT. THE DOCTOR SAID THAT THIS IS TOO DANGEROUS TO USE ON PATIENTS. THE SALES REP COMPARED THE BARBED SUTURE THAT HAD AS A SHAPE SAMPLE WITH ANOTHER BARBED SUTURE IN THE HOSPITAL THAT WASN'T USED CLINICALLY, AND IT SEEMS THAT THE BARB ON THE BARBED SUTURE IS SLIGHTLY WEAK. IT WAS NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045678 ↗
• MalfunctionApr 28, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. SURGEON USED THE SUTURE FOR UTERUS CLOSURE AND AS HE WAS PULLING, THE SUTURE SNAPPED AT THE NEEDLE. HE WAS PULLING THE SUTURE BY PULLING THE NEEDLE HOLDER AND NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WERE NO SURGICAL DELAYS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015180 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 026 AND BARBED SUTURE WAS USED. THE DOCTOR WAS SUTURING THE UTERUS DURING A C-SECTION AND TWO STRANDS OF BARBED SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941030 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE DOCTOR WAS SUTURING THE UTERUS DURING A C-SECTION AND TWO STRANDS OF BARBED SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940998 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING SURGERY, THE SUTURE AND NEEDLE AT THE PROXIMAL END WAS DETACHED FROM THE NEEDLE EASILY. THIS ONLY HAPPENED WITH ONE NEEDLE/SUTURE. THE OTHER NEEDLES/SUTURES DID NOT HAVE ANY PROBLEMS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716962 ↗
• MalfunctionMar 17, 2026Positioning Failure; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, SINCE THE BEGINNING OF THIS YEAR, THE DOCTOR REPORTED THAT APPROXIMATELY 2 SUTURES IN TOTAL, ABOUT 1 OUT OF EVERY 7 TO 8 SUTURES, HAD POOR TISSUE PASSAGE. THIS PHENOMENON WAS DESCRIBED AS THE SUTURE HAVING A KNOT SO THAT IT GETS CAUGHT. AS THE PRODUCT HAS BEEN USED FOR A LONG TIME, THE DOCTOR SAID THAT LOCKING DURING SUTURING IS UNLIKELY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. 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 24619145 ↗
• MalfunctionMar 17, 2026Positioning Failure; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, SINCE THE BEGINNING OF THIS YEAR, THE DOCTOR REPORTED THAT APPROXIMATELY 2 SUTURES IN TOTAL, ABOUT 1 OUT OF EVERY 7 TO 8 SUTURES, HAD POOR TISSUE PASSAGE. THIS PHENOMENON WAS DESCRIBED AS THE SUTURE HAVING A KNOT SO THAT IT GETS CAUGHT. AS THE PRODUCT HAS BEEN USED FOR A LONG TIME, THE DOCTOR SAID THAT LOCKING DURING SUTURING IS UNLIKELY. IT WAS NOT A CONTROL RELEASE NEEDLE. THE REPORTED PRODUCT WAS USED TO COMPLETE THE CASE. 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 24619144 ↗
• InjuryMar 10, 2026Break

  IT WAS THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE PATIENT WAS READMITTED TO THE HOSPITAL AS THERE WAS AN ENTIRE SECTION OF SUTURE MISSING FROM THE WOUND CLOSURE AS IF IT HAD BEEN COMPLETELY ABSORBED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Wound Dehiscence

  MAUDE report 24560941 ↗
• MalfunctionJan 22, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DR WAS USING STRATAFIX (SXPP1B408) TO CLOSE THE UTERUS DURING A C-SECTION CASE, BUT AS SHE WAS SUTURING, THE SUTURE DETACHED FROM THE NEEDLE (AT THE SWAGE). THE CIRCULATING NURSE OPENED A NEW STRAND AND THAT STRAND WAS OK (DID NOT DETACH LIKE THE FIRST STRAND) - DR USED THE SECOND STRAND TO CONTINUE CLOSING THE REMAINING OF THE UTERINE INCISION. AFTERWARDS, DUE TO CONCERNS FOR PATIENT SAFETY, SHE REINFORCED THE CLOSURE WITH VICRYL KNOTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144082 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A C-SECTION ON (B)(6) 2025 AND A BARBED SUTURE WAS USED FOR UTERINE CLOSURE. POST-OP, THE PATIENT EXPERIENCED AN INFECTION ON (B)(6) 2025, THE SURGEON ONLY GAVE FEEDBACK THAT THE PATIENT EXPERIENCED INFECTION ON (B)(6) 2025, THEREFORE IT IS UNSURE AS TO WHEN EXACTLY THE INFECTION OCCURRED. THE PATIENT EXPERIENCED A SMALL INFECTION COLLECTION ON THE UTERUS AT AN AREA ABOVE THE SUTURE LINE. THE SURGEON DID NOT NEED TO GO IN FOR A REOPERATION. THE INFECTION WAS DEALT WITH VIA DRAINAGE OF THE COLLECTION AND THE PATIENT HAS RECOVERED WELL. THE SURGEON DID NOT DIRECTLY RELATE THE CAUSE OF INFECTION TO THE BARBED SUTURE AS THE INFECTION WAS NOT ON THE INCISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 23848753 ↗
• MalfunctionJul 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE DURING USE AND USE WAS STOPPED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 22680673 ↗
• MalfunctionJul 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY WHEN SUTURING AND THE SUTURE WAS PULLED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420900 ↗
• MalfunctionJun 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE DURING SURGERY AT THE OPERATION ROOM WHEN THE PACKAGE WAS OPENED. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22215498 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) AND BARBED SUTURE WAS USED. DURING A CAESAREAN SECTION, IT WAS FOUND THAT THE LOOP HAD BEEN DETACHED. THIS EVENT OCCURRED FOR THE FIRST TIME. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114976 ↗
• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, 0 STRATAFIX SPIRAL PDS SNAPPED ON FIRST PASS. SUTURE UNABLE TO BE USED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426925 ↗
• MalfunctionDec 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP ARTHROSCOPY IN 2024 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE WHILE PASSING THROUGH TISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20987434 ↗
• MalfunctionJan 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LSCS PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE BARBED SUTURE WAS USED FOR CLOSURE DURING LSCS AND THE NEEDLE DETACH FROM SWAGE WHILE SUTURING. HCP WAS ABLE TO FIXATE THE FIXATION LOOP AND THE APEX WITH NO ISSUES AND THE NEEDLE DETECT HALFWAY WHILE SUTURING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO FRAGMENTS GENERATED AND NO DELAY DUE TO REPORTED EVENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489377 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726141 ↗
• InjuryApr 27, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. APPROXIMATELY 4-6 WEEKS POST OPERATIVELY THE PATIENT HAD A BIG FALL AND THE PATIENT'S WOUND DEHISCED. THE PATIENT RETURNED FOR RECLOSURE OF THE WOUND. IT WAS POSSIBLE THAT THE BARBED SUTURE WAS BROKEN IN THE MIDDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable; Wound Dehiscence

  MAUDE report 7470668 ↗