STRATAFIX SXPP1B455Recalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 10705031240834), received between Apr 18, 2018 and Jul 2, 2026 — classified as 15 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Break” (52 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 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SPIRAL SUTURE STARTED FRAYING. ATTEMPTED TO OPEN ANOTHER AND USE. SAME THING HAPPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25695442 ↗
• MalfunctionMay 27, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, NEEDLE DETACHED FROM THREAD WHEN REMOVING FROM PORT DURING LAPAROSCOPIC CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25304509 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE IN (B)(6) 2026 AND BARBED SUTURE WAS USED.DU RING MYOMECTOMY, FIRST STRATAFIX SUTURE BROKE. 1 OF 3 STRATAFIX SPIRAL USED FOR CASE. CASE COMPLETED WITHOUT ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191717 ↗
• MalfunctionJan 9, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE NEEDLE CAME/POP OFF THE STRAND DURING VAGINAL VAULT CLOSURE (NORMAL USE). THE NEEDLE THAT CAME OFF SUTURE WAS ACCIDENTLY DISCARDED BY SCRUB TECH, JUST STERILE SAMPLES OF SAME LOT # BEING RETURNED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030406 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, STRATAFIX SUTURE BROKE/FRAYED WHILE SUTURING VAGINAL CUFF. SURGEON GRASPED SUTURE WITH INSTRUMENT/NEEDLE DRIVER/GRASPER AS PER USUAL PRACTICE AND SUTURE BROKE. GRASPER CHECKED FOR SHARP EDGES AND NONE NOTED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926711 ↗
• MalfunctionDec 30, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. STRATAFIX NEEDLE CAME OFF SUTURE WHEN TRYING TO REMOVE THROUGH TROCAR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923245 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. SITE CALLED TO ADVISE A NEEDLE BROKE OFF STRATAFIX SPIRAL SUTURE WHILE CLOSING THE VAGINAL VAULT IN A LAP HYSTERECTOMY WHILE SUTURING NORMALLY. SITE MATERIALS MANAGER SPOKE WITH ANOTHER SITE WHO EXPERIENCED THE SAME THING AND EXPRESSED CONCERN AS IT WAS THE SAME LOT #. NEEDLE AVAILABLE FOR REVIEW BUT NOT SUTURE. DID NOT INDICATE WHERE IN THE SUTURE SEQUENCE THE NEEDLE CAME OFF. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853649 ↗
• InjuryDec 19, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL LAP SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE FELL OFF SUTURE WHILE IN THE ABDOMEN. SURGEON UNABLE TO LOCATE NEEDLE. INTRA OP XRAY DONE TO DETERMINE NEEDLE IN ABDOMEN. LAP SURGERY CONVERTED TO OPEN TO LOCATE NEEDLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23850366 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED TO THE SALES REP THAT THERE AN ISSUE ON PRODUCT SNAPPING DURING SUTURE VAGINAL CASE. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819347 ↗
• MalfunctionNov 3, 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 TO THE SALES REP THAT ON THE FIRST SUTURE NEEDLE CAME OFF THE WHEN THERE PASSING IT TO THE TROCAR AND ON THE SECOND ONE SUTURE BROKE WHILE THE SURGEON USING IT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455994 ↗
• MalfunctionNov 3, 2025Break; Break

  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 TO THE SALES REP THAT ON THE FIRST SUTURE NEEDLE CAME OFF THE WHEN THERE PASSING IT TO THE TROCAR AND ON THE SECOND ONE SUTURE BROKE WHILE THE SURGEON USING IT. THERE WERE NO PATIENT ADVERSE EVENT. PRODUCT IS NOT FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23455270 ↗
• MalfunctionOct 15, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE DETACH FROM SWAGE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290618 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT WHILE CLOSING THE CUFF DURING ROBOTIC HYSTERECTOMY, THE SUTURE BROKE 3 TIMES. TYPICALLY 1 SUTURE IS USED TO COMPLETE THIS CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED. THE BROKEN SUTURE WITH NEEDLES INTACT WERE REMOVED FROM THE ABDOMEN. THE SURGERY PROCEEDED IN USUAL FASHION. THE 3 SUTURES WERE FROM THE SAME LOT #. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884465 ↗
• MalfunctionAug 22, 2025Break; Break

  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 WHILE CLOSING THE CUFF DURING ROBOTIC HYSTERECTOMY, THE SUTURE BROKE 3 TIMES. TYPICALLY, 1 SUTURE IS USED TO COMPLETE THIS CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED. THE BROKEN SUTURE WITH NEEDLES INTACT WERE REMOVED FROM THE ABDOMEN. THE SURGERY PROCEEDED IN USUAL FASHION. THE 3 SUTURES WERE FROM THE SAME LOT #. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877090 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT WHILE CLOSING THE CUFF DURING ROBOTIC HYSTERECTOMY, THE SUTURE BROKE 3 TIMES. TYPICALLY 1 SUTURE IS USED TO COMPLETE THIS CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED. THE BROKEN SUTURE WITH NEEDLES INTACT WERE REMOVED FROM THE ABDOMEN. THE SURGERY PROCEEDED IN USUAL FASHION. THE 3 SUTURES WERE FROM THE SAME LOT #. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877088 ↗
• MalfunctionAug 22, 2025Break; Break

  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 WHILE CLOSING THE CUFF DURING ROBOTIC HYSTERECTOMY, THE SUTURE BROKE 3 TIMES. TYPICALLY, 1 SUTURE IS USED TO COMPLETE THIS CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED. THE BROKEN SUTURE WITH NEEDLES INTACT WERE REMOVED FROM THE ABDOMEN. THE SURGERY PROCEEDED IN USUAL FASHION. THE 3 SUTURES WERE FROM THE SAME LOT #. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877062 ↗
• MalfunctionAug 22, 2025Break; Break

  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 WHILE CLOSING THE CUFF DURING ROBOTIC HYSTERECTOMY, THE SUTURE BROKE 3 TIMES. TYPICALLY 1 SUTURE IS USED TO COMPLETE THIS CLOSURE. THE SUTURE WAS IMMEDIATELY REPLACED. THE BROKEN SUTURE WITH NEEDLES INTACT WERE REMOVED FROM THE ABDOMEN. THE SURGERY PROCEEDED IN USUAL FASHION. THE 3 SUTURES WERE FROM THE SAME LOT #. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877051 ↗
• MalfunctionJul 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PATIENT IS 4 MONTHS POST OP AND REPORTED HER PARTNER CAN FEEL THE BARBS OF THE SUTURE DURING INTERCOURSE. ADDITIONAL TISSUE HAS FORMED AROUND THE SUTURE SITE. DEVICE WAS NOT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Scar Tissue

  MAUDE report 22478423 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON (B)(6)2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS USING AN 0 9" CT-1 UNIDIRECTIONAL STRATAFIX SPIRAL PDS DURING A ROBOTIC HYSTERECTOMY FOR CLOSING THE VAGINAL CUFF. WHILE PULLING TENSION ON THE SUTURE DURING THE 3RD PASS, THE NEEDLE POPPED OFF OF THE SUTURE AT THE SWAGE. THERE WAS NO DAMAGE TO THE PATIENT AND THE SURGERY WAS DISRUPTED FOR ABOUT 2 MINUTES WHILE THEY WENT AND OPENED A VLOC SUTURE TO FINISH THE CLOSURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296804 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT A ROBOTIC HYSTERECTOMY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED IN THE MIDDLE OF THE VAGINAL CUFF. ON (B)(6) 2025, THE PATIENT RETURNED FOR A REOPERATION, DUE TO A DEHISCENCE. NO SUTURE IS LEFT, THE HOLE WAS SO BIG IT DID NOT LOOK LIKE IT HAD CLOSED AT ALL. IT IS UNKNOWN HOW THE HOLE WAS FIXED. SALES REP DOES KNOW THAT THE SURGEON LIKES TO USE A DIFFERENT SUTURE ON THE ENDS. AND THEN SIZE 0 BARBED SUTURE IN THE MIDDLE OF THE VAGINAL CUFF. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22111442 ↗
• InjuryMay 13, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SEROMA OR HEMATOMA. THE SUTURE MATERIAL WAS NOT HOLDING TISSUE COMPRESSED ADEQUATELY. THE PATIENT DID NOT REQUIRE AN EMERGENCY DEPARTMENT VISIT AND IT WAS HANDLED IN THE OFFICE ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Seroma; Wound Dehiscence

  MAUDE report 22012057 ↗
• InjuryMay 13, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SEROMA OR HEMATOMA. THE SUTURE MATERIAL WAS NOT HOLDING TISSUE COMPRESSED ADEQUATELY. THE PATIENT REQUIRED AN EMERGENCY DEPARTMENT VISIT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Seroma; Wound Dehiscence

  MAUDE report 22012051 ↗
• InjuryMay 13, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED A SEROMA OR HEMATOMA. THE SUTURE MATERIAL WAS NOT HOLDING TISSUE COMPRESSED ADEQUATELY. THE PATIENT REQUIRED AN EMERGENCY DEPARTMENT VISIT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hematoma; Seroma; Wound Dehiscence

  MAUDE report 22012033 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A ROBOTIC HYSTERECTOMY PROCEDURE THAT THE SUTURE BROKE WHILE SUTURING THE VAGINAL CUFF. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005185 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING A ROBOTIC HYSTERECTOMY PROCEDURE THAT THE SUTURE BROKE WHILE SUTURING THE VAGINAL CUFF. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005181 ↗