STRATAFIX SXMP1B427Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 10705031236516), received between Dec 15, 2017 and Sep 29, 2026 — classified as 3 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Break” (56 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 114 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931296 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930988 ↗
• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848221 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543110 ↗
• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373735 ↗
• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305531 ↗
• MalfunctionAug 11, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213810 ↗
• InjuryAug 6, 2026Break; Material Separation

  It was reported that during laparoscopic endometriosis surgery on (b)(6) 2026 and a barbed suture was used. During the procedure, after the suture needle passed through the tissue and when suturing the endometrium, pulling off suture needle happened upon suture lifting and the needle fell into the abdominal cavity of the patient. It took more than 1 hour to find the needle in patient¿s abdominal cavity, and the surgical incision on the abdominal wall of the patient was enlarged. The patient was in normal condition currently. Additional information was requested.

  Patient problems: Insufficient Information

  MAUDE report 50160128 ↗
• MalfunctionAug 5, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50141767 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PARTIAL OMENTECTOMY AND BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE SURGICAL PROCEDURE OF SUTURING THE INCISION WITH SUTURE, IT WAS FOUND THAT THE SUTURE HAD BROKEN BEFORE THE FIRST STITCH WAS COMPLETED. NORMAL SUTURING, NO RESISTANCE ENCOUNTERED, NO FORCED PULLING. STOP USING, SUCCESSFULLY COMPLETE THE INCISION SUTURE AFTER REPLACING THE SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322381 ↗
• MalfunctionMay 20, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TAPP PROCEDURE ON (B)(6) 2026 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. 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 25229760 ↗
• MalfunctionMay 19, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. AFTER REINFORCING THE ANASTOMOTIC SITE WITH SUTURE, IT BECAME LOOSE AND UNSTABLE. IT WAS RE REINFORCED DURING SURGERY AND THE END SUTURE WAS TIED AND FIXED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25215758 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SHOULD BE BILE DUCT PROCEDURE ON(B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127396 ↗
• MalfunctionApr 23, 2026Material Separation

  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 THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED 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 24972807 ↗
• MalfunctionApr 15, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY TUMOR PROCEDURE ON (B)(6) 2026 BARBED SUTURE WAS USED. DURING THE PROCESS OF SUTURING WITH SUTURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. IT WAS REPLACED IMMEDIATELY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889124 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NAVEL HERNIA TAPP SURGERY ON (B)(6) 2026 AND BARBED SUTURE WAS USED. WHILE SUTURING THE PERITONEUM DURING SURGERY, THE SUTURE BROKE. RESULTING IN PROLONGED SURGICAL TIME, MULTIPLE SUTURES WERE USED TO REPAIR THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793445 ↗
• MalfunctionMar 30, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED 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 24716465 ↗
• MalfunctionMar 12, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRECTOMY ON(B)(6) , 2026 AND BARBED SUTURE WAS USED. 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24583745 ↗
• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. THE OPERATION WAS DONE WELL AND THE WOUND WAS FINE IN FIRST DRESSING TIME AFTER SURGERY. HOWEVER, RECENTLY THE PATIENT FOUND THE WOUND WAS A LITTLE BIT OPENED AROUND 1CM. IT HAD BEEN 2 MONTHS SINCE THE FIRST DRESSING, SO THE PATIENT GOT ANOTHER DRESSING TO HANDLE WOUND THE COMPLICATION. THE PATIENT CONDITION IS FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 24530276 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED A PATIENT UNDERWENT AN LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. AT 11:20, DURING THE PREPARATION PROCESS, THE SUTURE BROKE AND WAS SUBSEQUENTLY REPLACED. NO REPORTED ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523782 ↗
• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN DURING THE SURGERY. INCREASED PATIENT SAFETY HAZARDS AND PROLONGED SURGICAL TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393044 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, THE NEEDLE TIP BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE BROKEN NEEDLE WAS RETRIEVED SHORTLY. THE PROCEDURE WAS COMPLETED AND NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303661 ↗
• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. AT THE TIME THE SURGEON REMOVED THE THREAD FROM THE CAVITY; AFTER SUTURING THE STRUCTURES, THE THREAD RUPTURED DURING ITS REMOVAL BY THE TROCAR. THE NEEDLE WAS LOCATED IN THE TUB OF THE OPERATING TABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24303538 ↗
• MalfunctionJan 16, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHEN SURGEON WANT TO USE BARBED SUTURE, NEEDLE DETACH FROM SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095148 ↗
• MalfunctionJan 14, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC BILATERAL INGUINAL HERNIA PATCH REPAIR VIA RETROPERITONEUM PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE PATIENT WAS HOSPITALIZED FOR SURGERY DUE TO BILATERAL INGUINAL HERNIA. DURING THE SURGERY, THE DOCTOR USED ARTIFICIAL PATCH/HERNIA REPAIR PATCHES ON BOTH SIDES AND USED SUTURE FOR SUTURING. AFTER COMPLETING THE FIRST TWO STITCHES, WHEN ATTEMPTING TO SEW THE THIRD ONE, IT WAS FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED AND COULD NO LONGER BE USED. A NEW SUTURE WAS REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24072554 ↗