STRATAFIX SXPP1B413Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10705031236165), received between Nov 5, 2018 and Mar 23, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Break; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC OVARIAN CYSTECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALE REP THAT DURING A ROBOTIC OVARIAN CYSTECTOMY PROCEDURE THE SURGEON COMPLETED EXCISION OF THE OVARIAN CYST AND BEGAN CLOSING THE OVARY. WHILE PERFORMING THE CLOSURE WITH STRATAFIX, THE SUTURE BEGAN TO SLIP AND UNRAVEL, DESPITE THE SURGEON HAVING EXECUTED TWO BACK PASSES IN ACCORDANCE WITH STANDARD TECHNIQUE. DUE TO THE SUTURE NOT MAINTAINING HOLD, THE SURGEON ELECTED TO SWITCH TO A COMPETITIVE PRODUCT TO COMPLETE THE CLOSURE. THIS RESULTED IN ADDITIONAL OPERATIVE TIME BEING REQUIRED TO SUCCESSFULLY FINISH THE CASE. 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 24666205 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ROBOTIC PROCEDURE ON 3/8/2024; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE FROM THE SUTURE. THEY LUCKILY FOUND THE NEEDLE BACK IN THE PATIENT¿S BODY/ THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961155 ↗
• MalfunctionNov 9, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN GYN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, TWO STAFF SURGEONS WERE USING A SUTURE AND IT DID NOT HOLD THE TISSUES. IT "WENT RIGHT THROUGH". THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18105114 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE DEVICE BROKE AFTER A FEW PASSES WITHIN THE TISSUE DURING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836973 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN ROBOTIC INGUINAL HERNIA PROCEDURE ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. DURING THE END OF THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THEY PUT A BIGGER TROCAR IN TO TAKE THE NEEDLE OUT ALONG WITH THE BAG. NO PATIENT CONSEQUENCES REPORTED. NO DEVICE AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643232 ↗
• InjuryNov 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SCOLIOSIS PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED SUTURE SPITTING ON AN UNKNOWN DATE. THE SURGEON REMOVED THE SUTURE TO RESOLVE THE ISSUE. THE CURRENT PATIENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8102578 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL LAMINECTOMY PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE SUBCUTANEOUS TISSUE. ON UNKNOWN DATE POST OP, THE PATIENT EXPERIENCED SUTURE SPITTING. THE PATIENT EXPERIENCED AN INFECTION ON AN UNKNOWN DATE AND AN ADDITIONAL PROCEDURE WAS PERFORMED ON (B)(6) 2018 FOR CLEANSING. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: No Code Available; Not Applicable; Unspecified Infection

  MAUDE report 8039621 ↗
• InjuryNov 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL LAMINECTOMY PROCEDURE ON UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE SUBCUTANEOUS TISSUE. ABOUT EIGHT TO TEN WEEKS POST OP, THE PATIENT EXPERIENCED SUTURE SPITTING. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE SUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8039560 ↗