STRATAFIX SXPP1B405Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031236080), received between Jun 26, 2019 and Dec 11, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT WHEN THE SURGEON WAS TRYING TO CLOSE THE VAGINAL CUFF, THE SUTURE STARTED FRAYING. ANOTHER DEVICE LIKE WAS USED TO CONTINUE WITH THE PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. DEVICE IS FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778214 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SURGEON THAT THE NEEDLE POPPED OFF OF THE SUTURE WHEN ATTEMPTING TO REMOVE FROM THE TROCAR. 8MM AIRSEAL BRAND TROCAR USED WITH A CT-2 NEEDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284459 ↗
• InjuryJul 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. THE SURGEON NOTICED THAT THE SUTURE DID NOT CINCH AS WELL AS A COMPETITOR PRODUCT. IN THE PATIENT, A HEMATOMA RESULTED AND SUBSEQUENT ABSCESS FORMED WHICH NEEDED TO BE TREATED WITH RE-HOSPITALIZATION, AN INCISION AND DRAINAGE PROCEDURE AND SEVERAL DAYS OF ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Hematoma

  MAUDE report 17406399 ↗
• InjuryJul 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. THE SURGEON NOTICED THAT THE SUTURE DID NOT CINCH AS WELL AS A COMPETITOR PRODUCT. IN THE PATIENT, A HEMATOMA RESULTED AND SUBSEQUENT ABSCESS FORMED WHICH NEEDED TO BE TREATED WITH RE-HOSPITALIZATION, AN INCISION AND DRAINAGE PROCEDURE AND SEVERAL DAYS OF ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Hematoma

  MAUDE report 17406396 ↗
• InjuryJul 27, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. THE SURGEON NOTICED THAT THE SUTURE DID NOT CINCH AS WELL AS A COMPETITOR PRODUCT. IN THE PATIENT, A HEMATOMA RESULTED AND SUBSEQUENT ABSCESS FORMED WHICH NEEDED TO BE TREATED WITH RE-HOSPITALIZATION, AN INCISION AND DRAINAGE PROCEDURE AND SEVERAL DAYS OF ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Hematoma

  MAUDE report 17406394 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR MENTIONED THAT WHILE USING STRATAFIX SPIRAL WITH THE ROBOT THE SUTURE FRAYED AND BROKE. HE USED AN ADDITIONAL SUTURE TO COMPLETE THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. STATUS OF PATIENT CONSEQUENCES IS UNKNOWN. DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009741 ↗
• MalfunctionSep 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE (B)(6)2022 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO READ THE QR CODE ON THE SUTURE PACKAGING. IT WAS NOTED THAT THE PROBLEM WAS NOT WITH THE READER, BUT IN THE QUALITY OF PRINTING THE QR CODE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499593 ↗
• MalfunctionMay 9, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT RETURNED FOR IN OFFICE CHECKUP AN ESTIMATED 3 MONTH POST-OP AND THE DOCTOR COULD STILL SEE SOME OF THE BARBED SUTURE LOOP ON CUFF CLOSURE. NO PATIENT CONSEQUENCE AND NO WOUND ISSUES., THE DOCTOR JUST DIDN¿T EXPECT TO SEE THE PRODUCT DURING EXAMINATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338564 ↗
• MalfunctionMay 9, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT RETURNED FOR IN OFFICE CHECKUP AN ESTIMATED 3 MONTH POST-OP AND THE DOCTOR COULD STILL SEE SOME OF THE BARBED SUTURE LOOP ON CUFF CLOSURE. NO PATIENT CONSEQUENCE AND NO WOUND ISSUES., THE DOCTOR JUST DIDN¿T EXPECT TO SEE THE PRODUCT DURING EXAMINATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337392 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. WITH THE SAME NEEDLE-SUTURE, SUTURE BREAKAGE OCCURRED TWICE. 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 13578569 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. WITH THE SAME NEEDLE-SUTURE, SUTURE BREAKAGE OCCURRED TWICE. 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 13578393 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OB-GYN ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. WITH THE SAME NEEDLE-SUTURE, SUTURE BREAKAGE OCCURRED TWICE. 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 13578385 ↗
• MalfunctionFeb 26, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2021 AND THE BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE WHILE CLOSING THE VAGINAL CUFF. A NEW SUTURE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388487 ↗
• MalfunctionFeb 26, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2021 AND THE BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE WHILE CLOSING THE VAGINAL CUFF. A NEW SUTURE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388463 ↗
• MalfunctionFeb 26, 2021Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2021 AND THE BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND BROKE WHILE CLOSING THE VAGINAL CUFF. A NEW SUTURE OF A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11388460 ↗
• InjuryDec 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2020 AND THE BARBED SUTURE WAS USED TO CLOSE VAGINAL CUFF WITH DOUBLE LAYER. THREE WEEKS POST OP, THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND HAD TO BE RE-OPERATED. DURING RE-OPERATION, IT WAS NOTICED THE VAGINAL CUFF WAS WIDE OPEN AND NO SUTURE PRESENT AT ALL ON VAGINAL CUFF. THE VAGINAL CUFF WAS COMPLETELY DEHISCED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11030473 ↗
• MalfunctionDec 12, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE SUTURE BROKE IN THE MIDDLE. THE SURGEON TIED THE SUTURE OFF AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460272 ↗
• InjuryJun 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2019 AND SUTURE WAS USED ON THE UTERUS. ON THE LAST PASSAGE, THE NEEDLE BROKE AND TWO-THIRDS OF NEEDLE WENT INTO THE UTERUS. AN XRAY WAS PERFORMED TO LOCALIZE THE NEEDLE. ONCE THE NEEDLE WAS LOCALIZED INTO THE UTERINE TISSUE, AN INCISION WAS MADE LATERALLY WITH THE BIGGEST TROCAR (12 MM) CREATING AN INCISION OF MORE THAN 50 MM TO ELEVATE THE UTERUS AND TOUCH WITH HANDS TO FIND AND REMOVE THE NEEDLE. THE NEEDLE WAS RETRIEVED AND REMOVED FROM THE UTERUS AND OPERATION COMPLETED SUCCESSFULLY. THE CURRENT PATIENT STATUS IS REPORTED TO BE AT HOME.

  Patient problems: Not Applicable

  MAUDE report 8736668 ↗