STRATAFIX SXPP1B457Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10705031240896), received between Apr 27, 2021 and Aug 13, 2025 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT SURGEON WAS USING THE BARBES SUTURE FOR THE FIRST TIME DURING AN EVALUATION WHEN THE SUTURE BROKE AFTER 4 PASSES. SHE WAS DOING A ROBOTIC HYSTERECTOMY. THEY BROUGHT IN A VLOC TO FINISH THE VAGINAL CUFF CLOSURE. PROCEDURE WAS DELAYED BY 2 MINUTES. NO PATIENT CONSEQUENCES WAS REPORTED. ONE DEVICE IS RETUNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22794627 ↗
• MalfunctionAug 7, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING ROBOTIC HYSTERECTOMY, WHILE THEY WERE PUTTING THE NEEDLE INSIDE THE TROCAR IT DETACHED INTO THE LOOP. ADDITIONALLY, UPON CLOSING THE VAGINAL CUP THE SUTURE APPEARED FRAYED AND SUBSEQUENTLY BROKE APART. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738630 ↗
• MalfunctionJun 12, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE SURGEON NOTICED THAT THE BARBS ON THE SUTURE WERE NOT THERE LIKE THEY'RE SUPPOSED TO BE. HE WAS CONCERNED THAT IT WOULD HOLD. HE USED A DIFFERENT SUTURE FOR CLOSURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197673 ↗
• MalfunctionJun 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC TOTAL LAP HYSTERECTOMY PROCEDURE WITH A CYSTO ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED FROM THE NEEDLE AND COMPLETELY SEPARATED. THE NEEDLE APPARENTLY MOVED A GOOD BIT FROM THE CUSP TO THE LIVER. THE NEEDLE WAS RETRIEVED DURING PROCEDURE BY ROBOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT HARM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519863 ↗
• MalfunctionFeb 9, 2024Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SALES REP REPORTED THAT THE PRODUCT SPLIT ON THE THIRD PASS AND ON THE FOURTH PASS IT BROKE. NO PATIENT HARM REPORTED. DEVICE AVAILABILITY UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677046 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE THE SURGEON COMMENTED THAT THE SUTURE SEEMED TO SLIP BACK AND DIDN¿T SEEM TO GRAB THE TISSUE. SHE TERMINATED THE SUTURE BY TAKING AT LEAST TWO PASSES IN THE OPPOSITE DIRECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16456613 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE IN (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING USE THE SURGEON COMMENTED THAT THE SUTURE SEEMED TO SLIP BACK AND DIDN¿T SEEM TO GRAB THE TISSUE. SHE TERMINATED THE SUTURE BY TAKING AT LEAST TWO PASSES IN THE OPPOSITE DIRECTION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16456047 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT HAD POST OP BLEEDING AND HAD TO GO TO THE ER AND SURGEON PRESCRIBED ANTIBIOTICS. THE SURGEON DID NOT KNOW THE CAUSE OF THE BLEEDING. NO SUTURE BREAKAGE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16358349 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. FIVE WEEKS POST OP, THE PATIENT IS STILL EXPERIENCING BLEEDING. THE SURGEON WONDERS IF THE SUTURE DID NOT STAY SECURE. SHE HAS TRIALED THE SUTURE ON OTHER PATIENTS AND NO ISSUES. DOCTOR SAID THAT SHE DOESN'T FEEL LIKE THE SUTURE STAYS IN PLACE AS AGGRESSIVELY AS COMPETITOR PRODUCT WHEN INTRA-OP. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 15439907 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431695 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431686 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431676 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431651 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431647 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT RETURNED WITH A VAGINAL CUFF DEHISCENCE. TREATMENT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 15431635 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838179 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838157 ↗
• MalfunctionJun 27, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838032 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY SURGERY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE BARBED SUTURE BROKE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988051 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE IN (B)(6) 2021 AND THE BARBED SUTURE WAS USED AT THE VAGINAL CUFF. THE PATIENT WHICH HAD THE BARBED SUTURE USED ON HER LAST WEEK WAS RE-ADMITTED TO THE HOSPITAL WITH A PELVIC ABSCESS. TUBE WAS INSERTED TO DRAIN 10MM ABSCESS. IT WAS ALSO REPORTED THAT THE CUFF IS INTACT. AS OF RIGHT NOW, THE PATIENT IS UNDER MONITORING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 11732286 ↗
• InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE IN (B)(6) 2021 AND THE BARBED SUTURE WAS USED AT THE VAGINAL CUFF. THE PATIENT WHICH HAD THE BARBED SUTURE USED ON HER LAST WEEK WAS RE-ADMITTED TO THE HOSPITAL WITH A PELVIC ABSCESS. TUBE WAS INSERTED TO DRAIN 10MM ABSCESS. IT WAS ALSO REPORTED THAT THE CUFF IS INTACT. AS OF RIGHT NOW, THE PATIENT IS UNDER MONITORING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Abscess

  MAUDE report 11732270 ↗