STRATAFIX SXMP1B434Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031236530), received between Nov 16, 2023 and Sep 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Delivered as Unsterile Product

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931192 ↗
• MalfunctionAug 25, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438730 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324401 ↗
• MalfunctionMay 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHILE THE SUTURE PASS THROUGH THE LOOP, THE LOOP WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172691 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. WHILE CONTINUE SUTURING, THE LOOP WAS DETACHED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791315 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE BROKE. 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 23087612 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE BROKE. 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 23087476 ↗
• MalfunctionSep 18, 2025Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085936 ↗
• MalfunctionAug 21, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT A HOLE WAS OBSERVED IN THE FOIL PACKET. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED PRIOR TO USE. 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 22867762 ↗
• MalfunctionJul 30, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED DURING NORMAL CHECKING. NOT INVOLVED IN ANY SURGERY OR PATIENT WAS INVOLVED. PLEASE REFER TO THE ATTACHED PHOTO OF THE DEFECT PRODUCT. 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 22665405 ↗
• MalfunctionMay 16, 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 MEDICAL STAFF EXPERIENCED THE PROBLEM OF PULLING OFF SUTURE NEEDLE DURING THE SURGICAL SUTURE PROCESS, RESULTING IN THE NEEDLE FALLING INTO THE ABDOMINAL CAVITY. REMOVE THE FALLEN NEEDLE AND SUTURE IT AGAIN. CONSIDERING PRODUCTS FROM THE SAME MANUFACTURER AND BATCH NUMBER, IF SIMILAR PHENOMENA ARE NOT DETECTED IN A TIMELY MANNER, IT MAY CAUSE SERIOUS HARM TO PATIENTS AFTER USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036796 ↗
• MalfunctionApr 29, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE WHEN SUTURING, RESULTING IN THE NEEDLE FALLING INTO THE ABDOMINAL CAVITY. THE SURGEON REMOVED THE FALLEN NEEDLE AND SUTURED AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21925584 ↗
• MalfunctionJan 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC BILATERAL HERNIA REPAIR SURGERY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, ON THE AFTERNOON, AT 14:00, FOLLOWING THE DOCTOR'S ADVICE, THE SURGERY WAS PERFORMED. DURING THE LAPAROSCOPIC BILATERAL HERNIA REPAIR SURGERY OPERATION, THE CHIEF SURGEON USED A 10MM PUNCTURE DEVICE TO INSERT THE SUTURE INTO THE LAPAROSCOPE AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. THE NEEDLE WAS NOT SEEN, AND THE TEAM LEADER IMMEDIATELY REPORTED IT TO THE TEAM LEADER. THE TEAM LEADER CONTACTED THE C-ARM MACHINE FOR FLUOROSCOPY AND THE RADIOLOGY DEPARTMENT FOR IMAGING, BUT NO NEEDLE WAS FOUND IN THE PATIENT'S BODY. FINALLY, THE NEEDLE WAS FOUND ON THE SECOND LAYER OF CLOTH ON THE OPERATING TABLE, AND THE SURGERY CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173217 ↗
• MalfunctionAug 20, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT THE PRIMARY PACKAGE OF THE SUTURE WAS FOUND DAMAGED PRIOR TO USE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. DURING THE INSPECTION OF THE RETURNED SAMPLE, A HOLE WAS NOTED TO BE OUTSIDE TO IN CAUSED BY AN UNKNOWN OBJECT TRESPASSING ON THE COMPLETE FOIL PACKAGE. THIS HOLE IS AFFECTING THE PRODUCT INTEGRITY. BLUE INK WAS ALSO NOTED ON THE HOLE AREA. DUE TO THE DAMAGES FOUND ON THE DEVICE, THE COMPLAINT IS CONFIRMED, A POSSIBLE CAUSE FOR THESE CONDITIONS IS DUE TO IMPROPER HANDLING DURING TRANSIT OR STORAGE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20000608 ↗
• MalfunctionJun 7, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDUE ON (B)(6)2024 AND 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. THE NEEDLE DID NOT FELL INTO THE PATIENT . ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483883 ↗
• MalfunctionMar 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND BARBED SUTURE WAS USED. THE NEEDLE GOT BENT BEFORE USING ON THE PATIENT DURING THE SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913157 ↗
• MalfunctionNov 16, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BARIATRIC PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING SURGERY, THE NEEDLE TYPE WAS FOUND TO BE CUTTING NEEDLE WHEN OPENED THE PACKAGE, BUT ACTUALLY IT SHOULD BE A TAPER NEEDLE. 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 18149566 ↗