STRATAFIX SXPP1B427Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031236196), received between Jan 15, 2019 and Sep 29, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 35 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 50931710 ↗
• MalfunctionAug 17, 2026Positioning Failure

  Patient problems: Insufficient Information

  MAUDE report 50277260 ↗
• MalfunctionAug 17, 2026Positioning Failure

  Patient problems: Insufficient Information

  MAUDE report 50276802 ↗
• MalfunctionMay 15, 2026Break

  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 TOTAL 2 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 21 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 25190423 ↗
• MalfunctionMay 15, 2026Break

  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 TOTAL 2 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, AND THE SUTURE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WILL RETURN 21 REPRESENTATIVE SAMPLES FOR ANALYSIS. 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 25190395 ↗
• MalfunctionApr 20, 2026Material Separation; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LAPAROSCOPIC RADICAL RESECTION OF RIGHT COLON CANCER PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. THE DOCTOR USED SUTURE TO CLOSE THE COMMON OPENING DURING THE OPERATION. AFTER SUTURING TWO STITCHES, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. BESIDES, NEEDLE GOT BENT. 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 24931872 ↗
• MalfunctionApr 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN 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 IS NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931799 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 24886777 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 24886775 ↗
• MalfunctionApr 15, 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 TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 24884658 ↗
• MalfunctionApr 15, 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 TOTAL 2 PRODUCTS OCCURRED NEEDLE PULL OFF ISSUE. 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 24884657 ↗
• MalfunctionDec 22, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOSCOPY 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 THORACOSCOPIC WEDGE RESECTION OF THE LUNG 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 23867799 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN THYROIDECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE BROKE WHEN SEWING IN AN UNKNOWN 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 23496621 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 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. 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 22864055 ↗
• MalfunctionJul 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PROBLEM OF THE SUTURE PULLING OFF THE NEEDLE HAPPENED IN 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 22382137 ↗
• MalfunctionJun 18, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT THE SUTURE WAS DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286528 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE NEEDLE WAS BROKEN WHEN IT WAS USED ONCE. NO PIECES WERE LEFT INSIDE THE PATIENT. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916913 ↗
• MalfunctionOct 31, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT COLORECTAL SURGERY ON (B)(6) 2024 A BARBED SUTURE WAS USED. PRIOR TO USE ON PATIENT, IT WAS REPORTED THAT THE NEEDLE HAD BEEN FOUND BROKEN IN THE NEWLY DISPENSED SUTURE WHEN PREPARING FOR SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, A FRACTURE WAS OBSERVED AT THE SUTURE ATTACHMENT OF THE NEEDLE. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579983 ↗
• MalfunctionOct 11, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCTOCOLECTOMY PROCEDURE ON (B)(6) 2024 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20428682 ↗
• MalfunctionAug 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROSTATECTOMY WITH DAVINCI PROCEDURE ON (B)(6)2024 AND BARBED SUTURE WAS USED. THE THREAD WAS ALREADY LOOSENED WHEN IT WAS REMOVED. THE THREAD WAS LOOSENED FROM THE NEEDLE AFTER THREE STITCHES IN SITUS. NO SIGNIFICANT PROCEDURE DELAYED WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SAME LIKE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19971610 ↗
• MalfunctionJul 23, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATIC ODUODENUM PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT THE BARB DIRECTION OF THE SUTURE WAS FOUND OPPOSITE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE BARBS OF THE SUTURE WERE ORIENTED OPPOSITE TO THE CORRECT ASSEMBLY POSITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804938 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617087 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616768 ↗
• MalfunctionJun 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROINTESTINAL SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19616763 ↗
• MalfunctionMar 22, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LOBECTOMY PROCEDURE ON (B)(6)2024; AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963922 ↗