STRATAFIX SXPP1A423Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10705031245365), received between Jul 15, 2019 and May 4, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION TAP WAS DETACHED WHILE SUTURING THE VAGINAL CUFF. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073057 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE FIXATION LOOP WAS BROKEN WHILE SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24945213 ↗
• MalfunctionApr 17, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS FOUND THAT THERE HAD BEEN FLUFFY FOREIGN MATTER IMMEDIATELY ONCE OPENED THE PACKAGE WHEN PREPARING FOR SURGERY . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915558 ↗
• MalfunctionJan 26, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE WAS DETACHED FROM SUTURE CONTINUOUSLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179803 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE WAS DIVIDED WHEN THE SURGEON WAS USING IT IN THE ABDOMINAL. EVEN HE DIDN'T DO SUTURING DONE, OPENED NEW 3 PIECES BUT ALL WERE DIVIDED. HE WAS SUFFERING DURING OPERATION AND COMPLAINING ABOUT IT. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160156 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE WAS DIVIDED WHEN THE SURGEON WAS USING IT IN THE ABDOMINAL. EVEN HE DIDN'T DO SUTURING DONE, OPENED NEW 3 PIECES BUT ALL WERE DIVIDED. HE WAS SUFFERING DURING OPERATION AND COMPLAINING ABOUT IT. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160153 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE WAS DIVIDED WHEN THE SURGEON WAS USING IT IN THE ABDOMINAL. EVEN HE DIDN'T DO SUTURING DONE, OPENED NEW 3 PIECES BUT ALL WERE DIVIDED. HE WAS SUFFERING DURING OPERATION AND COMPLAINING ABOUT IT. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160141 ↗
• MalfunctionJan 23, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE AND SUTURE WAS DIVIDED WHEN THE SURGEON WAS USING IT IN THE ABDOMINAL. EVEN HE DIDN'T DO SUTURING DONE, OPENED NEW 3 PIECES BUT ALL WERE DIVIDED. HE WAS SUFFERING DURING OPERATION AND COMPLAINING ABOUT IT. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24160139 ↗
• MalfunctionAug 15, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGEON WHO WAS USING STRATAFIX SYMMETRIC DURING A BARBED SUTURE EVALUATION AT THE HOSPITAL. HE USED SYMMETRIC FOR HIS ROBOTIC MYOMECTOMY. WHEN HE CUT THE SUTURE IT SPLIT AND FRAYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816421 ↗
• MalfunctionAug 2, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOSCOPIC ASSISTED RADICAL RESECTION OF COLON CANCER SURGERY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED WHEN THE SURGEON ATTEMPTED TO ASSISTED INCISION. CHANGED ANOTHER ONE TO COMPLETE THE ENDOSCOPIC ASSISTED RADICAL RESECTION OF COLON CANCER SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17447055 ↗
• InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED HYSTERECTOMY ON (B)(6) 2019 AND BARBED SUTURE WAS USED TO CLOSE THE VAGINAL CUFF. THE PATIENT RETURNED ON AN UNKNOWN DATE, WITH EXTREME PAIN. THE DOCTOR REMOVED THE SUTURE FROM THE PATIENT. PATIENT CURRENT STATUS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Code Available; Pain

  MAUDE report 9788593 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE SUTURE BROKE APART FROM THE NEEDLE DURING USE. THE CASE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268116 ↗
• MalfunctionNov 1, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE SUTURE BROKE APART FROM THE NEEDLE DURING USE. THE CASE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268105 ↗
• MalfunctionJul 15, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE CUT FROM THE SWAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8790136 ↗