STRATAFIX SXPP1B432Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031246539), received between Sep 1, 2020 and Sep 30, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Frayed

  It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported that Dr used several sutures that day and when Dr is pulling them through with robotix they are fraying. Doctor is no longer using them and is known for using them a lot. There are no Adverse Impact on patient/user reported. Device is not available for return. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946389 ↗
• MalfunctionSep 30, 2026Material Frayed

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946385 ↗
• MalfunctionMay 28, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC ASSISTED HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A ROBOTIC ASSISTED HERNIA REPAIR, THE SURGEON WAS USING THE SUTURE WITH THE ROBOT INSIDE THE PATIENT SEWING THE MESH. AND DURING HIM SEWING, THEY NOTICED A PIECE OF THE SUTURE WAS FRAYED TOWARDS THE END OF THE NEEDLE WHERE HE WAS PULLING IT THROUGH THE TISSUE. HE WAS ABLE TO UTILIZE THE FULL PIECE OF THE SUTURE AND LOCK IT WITHOUT LEAVING THAT FRAYED PIECE IN THE PATIENT. HE CLIPPED IT OFF AND PULLED IT OUT AFTER HE WAS FINISHED WITH THE CLOSING DEFECT. NO PATIENT CONSEQUENCES SINCE THE PIECE WAS REMOVED FROM THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322006 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246869 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246833 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246827 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246822 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246817 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246810 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246804 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246799 ↗
• MalfunctionMay 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THE SALES REP THAT THERE ARE 10 EACH THAT NEED TO BE RETURNED. THE SUTURES SPLIT IN HALF IN THE PATIENT AND WAS LEFT IN THE PATIENT. THE NUMBER OF ITEMS IN THE SCRIPT WOULD ONLY ALLOW THE OPERATOR TO ENTER A SINGLE DIGIT NUMBER BUT THERE ARE 10 EACH TO BE RETURNED. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25246792 ↗
• MalfunctionFeb 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED 3 SUTURES BROKE DURING THE SAME SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240927 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED 3 SUTURES BROKE DURING THE SAME SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962727 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED 3 SUTURES BROKE DURING THE SAME SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962709 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED 3 SUTURES BROKE DURING THE SAME SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23962707 ↗
• MalfunctionDec 3, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. WHEN THE SURGEON WAS SEWING THE MESH THE BARBED SUTURE, THE NEEDLE POPPED OFF. THERE WERE NO PATIENT ADVERSE EVENTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707295 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THE SUTURE LOOSEN BROKE AND SHREDDED THE TISSUE CAUSING US TO DO MORE INVOLVE REPAIR. PRODUCT IS NOT FOR RETURN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23413823 ↗
• MalfunctionJul 25, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. THE END LOOP CAME UNDONE AFTER THEY TRIED PUTTING THE SUTURE IN THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22610306 ↗
• MalfunctionMay 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING A ROBOTIC HYSTERECTOMY, AFTER VAGINAL CUFF CLOSURE AS THEY WERE PULLING THE SUTURE OUT OF THE TROCAR. THE NEEDLE SNAPPED OFF THE SUTURE. CASE WAS COMPLETED. NO PATIENT HARM WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056596 ↗
• MalfunctionFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN BY UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE NEEDLE POPPED OFF AND GOT STUCK IN THE TROCAR. ANOTHER SUTURE FROM A DIFFERENT LOT WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460467 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT A SUTURE BROKE MID CLOSURE ON VAGINAL CUSP DURING A LAPAROSCOPIC HYSTERECTOMY. THEY GOT A ANOTHER ONE TO COMPLETE THE CLOSURE WITHOUT ANY PATIENT HARM AND NO BROKEN PIECES FELL INTO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653759 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX SUTURE BROKE. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE. NO PATIENT HARM. THE USED PRODUCT IS NOT AVAILABLE FOR RETURN BUT WILL BE SENDING BACK STERILE PACKS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19992150 ↗
• MalfunctionAug 15, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX SUTURE BROKE. THEY OPENED ANOTHER SUTURE TO COMPLETE THE CASE. NO PATIENT HARM. THE USED PRODUCT IS NOT AVAILABLE FOR RETURN BUT WILL BE SENDING BACK STERILE PACKS. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19991960 ↗
• MalfunctionAug 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE FELL OFF SUTURE, DISCONNECTION OF NEEDLE FROM SWAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955694 ↗