STRATAFIX SXPP1B406Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031236097), received between Feb 7, 2018 and Sep 23, 2026 — classified as 17 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874150 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THIS PRODUCT WAS USED FOR AN EMERGENCY C-SECTION, TWO NEEDLE-SUTURES OUT OF EIGHT WERE DETACHED IMMEDIATELY. IT WAS 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 23777862 ↗
• MalfunctionDec 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THIS PRODUCT WAS USED FOR AN EMERGENCY C-SECTION, TWO NEEDLE-SUTURES OUT OF EIGHT WERE DETACHED IMMEDIATELY. IT WAS 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 23777853 ↗
• MalfunctionAug 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT TWO SEPARATE ISSUES OCCUR IN THE SAME PROCEDURE. THE NEEDLE POPPED OFF AND A SECOND NEEDLE POPPED OFF ON ANOTHER SUTURE WHILE INSERTING IT. NO ADVERSE IMPACT TO THE PATIENT/USER WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738265 ↗
• MalfunctionAug 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT TWO SEPARATE ISSUES OCCUR IN THE SAME PROCEDURE. THE NEEDLE POPPED OFF AND A SECOND NEEDLE POPPED OFF ON ANOTHER SUTURE WHILE INSERTING IT. NO ADVERSE IMPACT TO THE PATIENT/USER WAS REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738229 ↗
• MalfunctionJun 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT POST OP OF AN UNKNOWN PROCEDURE, SOME GRANULATION GOING ON THE PDS IS NOT FULLY ABSORBED BY THE BODY. THEY WERE ABLE TO PULL SOME OF THE MATERIAL OUT. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Granuloma

  MAUDE report 22152265 ↗
• MalfunctionJun 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT POST OP OF AN UNKNOWN PROCEDURE, SOME GRANULATION GOING ON THE PDS IS NOT FULLY ABSORBED BY THE BODY. THEY WERE ABLE TO PULL SOME OF THE MATERIAL OUT. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES WILL BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Granuloma

  MAUDE report 22152099 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT HAD A DEHISCENCES IN THE LAST 9MONTHS-1 YEAR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22111449 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT A PATIENT UNDERWENT A HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT HAD A DEHISCENCES IN THE LAST 9MONTHS-1 YEAR. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22111446 ↗
• MalfunctionMay 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS ACTING ¿LIKE POP OFF¿ NEEDLES IN A ROBOTIC HYSTERECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110426 ↗
• MalfunctionMay 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP HYSTERECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS ACTING ¿LIKE POP OFF¿ NEEDLES IN A ROBOTIC HYSTERECTOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22110421 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ACTIVE OBESE WOMEN UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THEY ARE SIX WEEKS OUT, AND SEEN THREE DAYS AGO YESTERDAY. AND CAME IN FOR PAIN AND SPOTTING. STRATAFIX DYE TOTALLY CAME OFF AND WAS LIGHT GRAY WHITE. IT LOOKED STRINGY BUT DID NOT LOOK SEPARATED. HOWEVER THE SURGEON SAID THAT IF SHE HAD POKED HER FINGER THROUGH THE SKIN WOULD HAVE DEHISCED. SURGEON ADVISED NO SEX, AND MINIMAL ACTIVITY AND PRESCRIBED ANTIBIOTICS. POSSIBLE SUSPECTING OF DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22100657 ↗
• InjuryMay 28, 2025Adverse 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 WITH BILATERAL SALPINGECTOMY, RIGHT OOPHORECTOMY, EXTENSIVE EXCISION OF ENDOMETRIOSIS AND LEFT URETEROLYSIS ON (B)(6) 2025 AND BARBED SUTURE WAS USED. AT AROUND 6 WEEK POST OP SHE BEGAN WALKING AROUND AS SHE HAD IN THE PAST AS SHE WAS DOING SO WELL. DENIES INTERCOURSE OR VAGINAL BLEEDING. UPON CUFF CHECK, HOWEVER, IT WAS NOTED TO BE A ~1CM OPENING AT THE RIGHT APEX. SHE WAS GIVEN THE OPPORTUNITY TO HAVE THIS OBSERVED VS SURGICAL REPAIR AND SHE HAS CHOSEN THE LATTER. THE PATIENT HAD TO BE RE OPERATED ON (B)(6) 2025. THE WHOLE PIECE OF BARBED SUTURE CAME OUT/OFF LEAVING A HOLE BEHIND. THE PATIENT HAD A VAGINAL CUFF DEHISCENCE. THE HOLE WAS REPAIRED WITH A DIFFERENT TYPE OF SUTURE. NO SPECIAL CONDITIONS OR DIABETES THAT WOULD AFFECT HEALING. THE PATIENT WORKS AS A MAIL CARRIER AND WOULD LIKE TO BE CERTAIN THAT SHE HAS HEALED WELL PRIOR TO GOING BACK TO WORK. PATIENT LARGELY DENIES PELVIC OR ABDOMINAL PAIN. DENIES NAUSEA VOMITING, FEVERS, OR CHILLS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22100650 ↗
• InjuryMay 28, 2025Break; Break

  IT WAS REPORTED BY THE SALES REP THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY IN (B)(6) 2025 AND BARBED SUTURE WAS USED. FOUR MONTHS POST OP THE PATIENT HAD SEXUAL INTERCOURSE AND FELT A POP. THE PATIENT IS A BREAST CANCER SURVIVOR. PATIENT HAS BEEN HAVING A LOT OF SEX SINCE BEING CLEARED. WAS HAVING A LOT OF PAIN AND BLEEDING. PATIENT WAS SEEN IN THE OFFICE AND NOTED TO HAVE A VAGINAL CUFF DEHISCENCE. REPAIR DONE ON (B)(6) 2025. USED DIFFERENT SUTURES TO REPAIR. NONE OF THE BARBED SUTURE WAS LEFT AT ALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22100646 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091559 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091556 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OPERATIVELY, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091554 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091549 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091548 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091547 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091544 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091543 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091542 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091541 ↗
• InjuryMay 27, 2025Adverse 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 A BARBED SUTURE WAS USED FOR CLOSURE ON THE VAGINAL CUFF. POST-OP, THE PATIENT DEVELOPED A GRANULOMA. OUT OF AN AVERAGE OF 100 PATIENTS TEN OR SO OF THOSE PATIENTS WOULD RETURN WITH A GRANULOMA. ACROSS A FEW OF HIS COLLEAGUES NATIONALLY AND INTERNATIONALLY. OUT OF SOME OF THOSE WHEN THEY WOULD GO TO BURN THE GRANULOMAS THE SUTURE WOULD BE SEEN POKING THROUGH THE VAGINA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Pocket Erosion

  MAUDE report 22091540 ↗