STRATAFIX SXPP1A435Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10705031245211), received between Aug 3, 2020 and Apr 22, 2026 — classified as 10 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953283 ↗
• MalfunctionApr 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY . WHICH AFFECTED THE SURGICAL PROGRESS . DISCARDED . NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899273 ↗
• MalfunctionDec 30, 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. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. 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 23923814 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY OR A TRAM CASE PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO DIFFERENT THE FIRST WAS AN ABDOMINOPLASTY AND THE SECOND WAS A TRAM CASE, THE SUTURE BROKE, THE SWEDGE THE END OF THE NEEDLE CAME AWAY FROM THE SUTURE. CASES WERE COMPLETED WITH LIKE DEVICE. FROM THE SECOND CASE A NEEDLE WAS RETAINED FOR ANALYSIS. FROM THE FIRST CASE NOTHING WAS KEPT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286222 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINOPLASTY OR A TRAM CASE PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING TWO DIFFERENT THE FIRST WAS AN ABDOMINOPLASTY AND THE SECOND WAS A TRAM CASE, THE SUTURE BROKE, THE SWEDGE THE END OF THE NEEDLE CAME AWAY FROM THE SUTURE. CASES WERE COMPLETED WITH LIKE DEVICE. FROM THE SECOND CASE A NEEDLE WAS RETAINED FOR ANALYSIS. FROM THE FIRST CASE NOTHING WAS KEPT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286220 ↗
• MalfunctionMay 21, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061972 ↗
• MalfunctionMay 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ESOPHAGEAL PROCEDURE U ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF SUTURE PULLING OFF THE NEEDLE HAPPENED WHEN SEWING DURING 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 22048291 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT NEPHRECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22014128 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT NEPHRECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22014117 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT NEPHRECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22014113 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT NEPHRECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22014109 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT NEPHRECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED A DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22014108 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED ANOTHER ONE, FIXATION FEATURE BROKE DURING SURGERY. 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 20201012 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ASSISTED RADICAL GASTRECTOMY IN (B)(6) 2024 AND A BARBED SUTURE WAS USED ON THE MUSCLE FASCI/LINEA ALBA IN A CONTINUOUS SUTURING MANNER. THE INTRAOPERATIVE SEWING OPERATION WAS SMOOTH. ABOUT 4-5 DAYS AFTER THE SURGERY, THE PATIENT HAD DISCHARGE OF PUS AND WOUND REDNESS, SWELLING, ERYTHEMA AND INFLAMMATION. THE DOCTOR FOUND WOUND INFECTION AFTER EXAMINATION. THE WOUND WAS RE-OPENED AND THE SUTURE WAS REMOVED. THEN THE WOUND WAS RESEWED AND THE ABDOMEN WAS CLOSED. THE FREQUENCY OF EXCIPIENT REPLACEMENT WAS ALSO INCREASED, AFTER WHICH THE PATIENT'S WOUND HEALING WAS IMPROVED. THE PATIENT WAS IN STABLE CONDITION CURRENTLY, AND NO SUBSEQUENT ADVERSE EVENT REPORT WAS RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Erythema; Inflammation; Purulent Discharge; Unspecified Infection

  MAUDE report 19047320 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR THE DEFECT. THE PROCEDURE WAS DONE USING THE ROBOT. POST-OP, THE PATIENT EXPERIENCED A RECURRENT VENTRAL HERNIA. THE MESH WAS INTACT BUT DEFECT WAS OPEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 18610476 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT VENTRAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR THE DEFECT. THE PROCEDURE WAS DONE USING THE ROBOT. POST-OP, THE PATIENT EXPERIENCED A RECURRENT VENTRAL HERNIA. THE MESH WAS INTACT BUT DEFECT WAS OPEN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia

  MAUDE report 18610475 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951235 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN SURGERY, THE SUTURE WAS BROKEN DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949768 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. APPROXIMATELY 2 WEEKS POST-OP, THE PATIENT EXPERIENCED A WOUND DEHISCENCE AND UNDERWENT RE-OPERATION. DURING THE REPAIR, THE SURGEON COULD STILL SEE THE TAB OF THE SUTURE BUT IT LOOKED LIKE THE TISSUE DEHISCED. THE SURGEON OPINED THAT HE COULD NOT BE CERTAIN IF IT WAS A PROBLEM WITH THE SUTURE OR IF THERE MAY HAVE BEEN OTHER FACTORS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 17904767 ↗
• MalfunctionApr 20, 2023Material 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. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781365 ↗
• MalfunctionNov 22, 2022Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. THE DOCTOR WAS OPERATING AND CLOSING THE DEFECT WITH A DEVICE. THE SUTURE FRAYED AND SPLIT DOWN THE MIDDLE NEAR THE WEDGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847503 ↗
• MalfunctionJul 28, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE BROKE WHILE SEWING THE MYOMETRIUM AND THE NEEDLE FELL INTO PATIENT. THE SURGERY TIME PROLONGED MORE THAN HALF HOUR TO LOOK FOR AND RETRIEVED BROKEN NEEDLE FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124515 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED SEVERE STOMACH BLOATING. CT SCAN DONE SHOWN SMALL BOWEL STRANGULATION OCCURRED. THE PATIENT HAD TO BE WARDED FOR ONE WEEK MORE AND TREATED WITH MEDICATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Obstruction/Occlusion; Swelling/ Edema

  MAUDE report 14956659 ↗
• MalfunctionMar 8, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A APPENDECTOMY ON (B)(6) 2022 AND SUTURE WAS USED. DURING USE, THE NEEDLE BROKE IN HALF. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13698719 ↗
• MalfunctionAug 3, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC VENTRAL HERNIA REPAIR ON (B)(6) 2020 AND THE BARBED SUTURE WAS USED. AFTER TAKING THE BARBED SUTURE OUT OF THE ABDOMEN, THE NURSE SAW THAT THE BARBED SUTURE WAS FRAYING NEAR THE SWAGE, WHERE THE NEEDLE MEETS THE SUTURE. IT LOOKED LIKE THERE WERE TWO SEPARATED SUTURES FROM THE NEEDLE TO WHERE THE FIRST BARB STARTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES AND NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359578 ↗