STRATAFIX SXPP1B454Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10705031240841), received between Dec 17, 2019 and Jun 4, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE GOT SPLIT IN THE SUTURE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399133 ↗
• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25398974 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF OF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163676 ↗
• MalfunctionMay 13, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF OF THE NEEDLE HAPPENED IN THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163449 ↗
• MalfunctionMay 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. THE NEEDLE DID NOT FELL INTO THE PATIENT. THE LOT OF IP IS UNAVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352514 ↗
• MalfunctionApr 9, 2024Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC CUFF GASTRIC SURGERY ON (B)(6)2024 AND SUTURE WAS USED TO REINFORCE THE GASTROINTESTINAL ANASTOMOTIC SITE. WHEN THE FIRST STITCH WAS SUTURED, THE SUTURE WAS PULLED AND BROKEN, APPROXIMATELY 10CM AWAY FROM THE SUTURE. AFTER THE SUTURE WAS BROKEN, THE DOCTOR CUT THE SUTURE AND TOOK IT OUT OF THE PATIENT'S BODY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070316 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREAD BROKEN TWICE. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027855 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A FACE LIFT (RHYTIDECTOMY) ON AN UNKNOWN DATE IN 2024, AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THREAD BROKEN TWICE. THERE WAS NO PATIENT CONSEQUENCE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027774 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569237 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569236 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569234 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569233 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569232 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569230 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569228 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569227 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569226 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569225 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569224 ↗
• MalfunctionAug 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE DURING USE. THIS HAPPENED IN MANY PRODUCTS. THESE WERE NOT CONTROL RELEASE NEEDLES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569223 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11888565 ↗
• MalfunctionApr 9, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2021 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT WHILE SUTURING THE STOMACH AND ESOPHAGUS BY CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE, AND THE NEEDLE WENT INTO THE BODY CAVITY. IT TOOK 3 HOURS TO FIND THE NEEDLE. IN THE END, IT WAS HIDDEN BEHIND THE SPLEEN, AND X-RAY WAS TAKEN 3 TIMES. THE OPERATION TIME WAS EXTENDED ABOUT 180 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11641083 ↗
• InjuryDec 17, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRECTOMY PROCEDURE ON (B)(6) 2019 AND BARBED SUTURE WAS USED. THE BARBED SUTURE WAS USED TO CLOSE THE STAPLED COMMON HOLE BY CONTINUOUS SUTURING DURING ANASTOMOSIS BETWEEN THE ESOPHAGUS AND JEJUNUM. SUTURING WAS DONE AS PER THE RECOMMENDED METHOD, AND TWO BACK STITCHES WERE PUT AT THE END OF SUTURING. THE SURGEON JUDGED THAT THE SUTURING WITH THE BARBED SUTURE WAS PERFORMED PROPERLY. THEN, THE SURGERY WAS COMPLETED. AFTER THE SURGERY, AN ANASTOMOTIC LEAKAGE OCCURRED. CONTINUOUS DRAINAGE WAS STARTED. DRAINAGE WAS ORIGINALLY PERFORMED, BUT DRAINAGE WAS PERFORMED LONGER THAN THE SCHEDULED PERIOD DUE TO A SUTURE FAILURE. THE LENGTH OF HOSPITAL STAY IS EXTENDED. AT PRESENT, THERE IS NO DANGER OF LIFE. PATIENT IS IN THE HOSPITAL BUT PROGRESS IS GOOD. ACCORDING TO THE SURGEON, THERE IS A TENDENCY THAT SUTURES WITH SMOOTH BARBS ¿MOVE BACK¿. THE SURGEON OPINES THAT THE ANASTOMOTIC LEAKAGE WAS CAUSED BY THE BARBED SUTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure to Anastomose

  MAUDE report 9478588 ↗