STRATAFIX SXPP1A425Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10705031245129), received between Jan 20, 2021 and Jul 30, 2026 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Laparoscopic surgical staging procedure on (b)(6) 2026 and barbed suture was used. On postoperative Day 15, wound dehiscence was observed at the cervical stump/vaginal cuff. Additional information was requested.

  Patient problems: Wound Dehiscence

  MAUDE report 50089820 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THERE WERE 3-4 STRANDS OF BARBED SUTURE THAT BROKE IN A ROBOTIC VENTRAL HERNIA CASE WITH SURGEON. THERE WAS FORCE BEING PUT UPON THE SUTURE WITH THE ROBOT ARMS WHICH COULD BE THE PRIMARY CAUSE, HOWEVER IN PAST CASES THIS HAS NOT BEEN AN ISSUE IN HER PROCEDURES. THE BREAKS PRIMARILY OCCURRED MIDWAY THROUGH THE SUTURE STRAND AFTER 3-4 CONTINUOUS PASSES. ANOTHER BREAK OCCURRED AT THE SUAGE SITE AFTER SHE HAD FINISHED HER 2 FINAL REVERSE LOCKING STITCHES. ADDITIONAL STRANDS OF THE SAME STRAND/CODE/BOX WERE USED TO CLOSE THE REMAINING PORTIONS OF THE DEFECT WITHOUT ISSUE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201014 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THERE WERE 3-4 STRANDS OF BARBED SUTURE THAT BROKE IN A ROBOTIC VENTRAL HERNIA CASE WITH SURGEON. THERE WAS FORCE BEING PUT UPON THE SUTURE WITH THE ROBOT ARMS WHICH COULD BE THE PRIMARY CAUSE, HOWEVER IN PAST CASES THIS HAS NOT BEEN AN ISSUE IN HER PROCEDURES. THE BREAKS PRIMARILY OCCURRED MIDWAY THROUGH THE SUTURE STRAND AFTER 3-4 CONTINUOUS PASSES. ANOTHER BREAK OCCURRED AT THE SUAGE SITE AFTER SHE HAD FINISHED HER 2 FINAL REVERSE LOCKING STITCHES. ADDITIONAL STRANDS OF THE SAME STRAND/CODE/BOX WERE USED TO CLOSE THE REMAINING PORTIONS OF THE DEFECT WITHOUT ISSUE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201012 ↗
• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THERE WAS 3-4 STRANDS OF BARBED SUTURE THAT BROKE IN A ROBOTIC VENTRAL HERNIA CASE WITH SURGEON. THERE WAS FORCE BEING PUT UPON THE SUTURE WITH THE ROBOT ARMS WHICH COULD BE THE PRIMARY CAUSE, HOWEVER IN PAST CASES THIS HAS NOT BEEN AN ISSUE IN HER PROCEDURES. THE BREAKS PRIMARILY OCCURRED MIDWAY THROUGH THE SUTURE STRAND AFTER 3-4 CONTINUOUS PASSES. ANOTHER BREAK OCCURRED AT THE SUAGE SITE AFTER SHE HAD FINISHED HER 2 FINAL REVERSE LOCKING STITCHES. ADDITIONAL STRANDS OF THE SAME STRAND/CODE/BOX WERE USED TO CLOSE THE REMAINING PORTIONS OF THE DEFECT WITHOUT ISSUE. NO SURGICAL DELAY OR PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201010 ↗
• MalfunctionApr 24, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE BEND AND SUTURE POP OFF FROM NEEDLE DURING PROCEDURE. AS PER HCP HE OPEN 8-9 SUTURES, BUT HE FACE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981657 ↗
• MalfunctionApr 24, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE BEND AND SUTURE POP OFF FROM NEEDLE DURING PROCEDURE. AS PER HCP HE OPEN 8-9 SUTURES, BUT HE FACE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981525 ↗
• MalfunctionApr 24, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE BEND AND SUTURE POP OFF FROM NEEDLE DURING PROCEDURE. AS PER HCP HE OPEN 8-9 SUTURES, BUT HE FACE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981484 ↗
• MalfunctionApr 24, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAP MYOMECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. NEEDLE BEND AND SUTURE POP OFF FROM NEEDLE DURING PROCEDURE. AS PER HCP HE OPEN 8-9 SUTURES, BUT HE FACE SAME ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24981463 ↗
• MalfunctionApr 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931687 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430791 ↗
• MalfunctionJan 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT KNEE JOINT REPLACEMENT SURGERY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060269 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE NEEDLE DID NOT FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866880 ↗
• MalfunctionDec 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839004 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LOBECTOMY ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN IT WAS PULLED DURING SUTURING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532121 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE HERNIA SAC. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905748 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE HERNIA SAC. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905723 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE HERNIA SAC. TOTAL 3 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905606 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UMBILICAL HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UMBILICAL HERNIA PROCEDURE, THE SUTURE BROKE OFF IN FOUR DIFFERENT PLACES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739581 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UMBILICAL HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UMBILICAL HERNIA PROCEDURE, THE SUTURE BROKE OFF IN FOUR DIFFERENT PLACES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739570 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A UMBILICAL HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UMBILICAL HERNIA PROCEDURE, THE SUTURE BROKE OFF IN FOUR DIFFERENT PLACES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739562 ↗
• MalfunctionAug 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING AN UMBILICAL HERNIA PROCEDURE, THE SUTURE BROKE OFF IN FOUR DIFFERENT PLACES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739561 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE WHILE DOING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646686 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, SUTURE BREAKAGE WHILE DOING THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646682 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT LAPAROSCOPIC MYOMECTOMY FOR UTERINE FIBROIDS PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON USED SUTURES TO SUTURE THE UTERUS, THE UTERUS HAD NOT BEEN FULLY SUTURED AND THE SUTURE BROKE. A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. THIS INCIDENT HAS INCREASED THE DEPARTMENT'S COST EXPENDITURES, AFFECTED THE SURGICAL PROCESS, AND POSED CERTAIN RISKS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127602 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHEN THE SURGEON USED SUTURE TO SUTURE THE UTERUS, THE UTERUS HAD NOT BEEN FULLY SUTURED AND THE SUTURE BROKE. A NEW SUTURE WAS IMMEDIATELY REPLACED FOR SUTURING. INCREASED THE COST EXPENDITURE OF THE DEPARTMENT. BUT IF POSTOPERATIVE RUPTURE OCCURS, THERE IS A RISK OF AFFECTING THE PATIENT'S HEALING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061685 ↗