STRATAFIX SXPP1B410Recalls & reported problems

Summary

The FDA's MAUDE database contains 200 adverse event reports that list this exact device (DI 10705031236134), received between May 2, 2018 and Sep 16, 2026 — classified as 9 injuries, 191 malfunctions.

The most frequently reported specific device problem is “Break” (148 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 200 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  It was reported that a patient underwent a Hysterectomy procedure on an unknown date and suture was used. The suture broke when sewing in an unknown 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 50788581 ↗
• MalfunctionSep 1, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547716 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533018 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532856 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532754 ↗
• MalfunctionAug 31, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50532660 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50305470 ↗
• MalfunctionAug 17, 2026Break; Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286631 ↗
• MalfunctionAug 4, 2026Material Separation

  It was reported that a patient underwent an unknown procedure on (B)(6) 2026 and a barbed suture was used. During the procedure, no abnormalities were found during the pre-use inspection. When sewing the first stitch with suture, the needle pull off issue happened, rendering it unusable. There were no adverse patient consequences reported. Additional information was requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132707 ↗
• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131847 ↗
• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON WAS USING ONE SPIRAL SUTURE S WHEN THE THREAD BROKE ROBOTICALLY. HE OPENED A SECOND ONE AND IT OCCURRED AGAIN. SURGICAL DELAY WAS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25695325 ↗
• MalfunctionJul 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE SURGEON WAS USING ONE SPIRAL SUTURE S WHEN THE THREAD BROKE ROBOTICALLY. HE OPENED A SECOND ONE AND IT OCCURRED AGAIN. SURGICAL DELAY WAS UNKNOWN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25695290 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REPRESENTATIVE THAT DURING A LAPAROSCOPIC MYOMECTOMY PROCEDURE, THE PHYSICIAN STATED THAT THE SUTURE STRAND SPLIT IN HALF DURING USE. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142667 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE SURGEON OF THE FACILITY HAS HAD AN ISSUE WITH THE BARBED SUTURE BREAKING AT THE NEEDLE DURING USAGE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056587 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY THE SALES REP THAT THE SURGEON OF THE FACILITY HAS HAD AN ISSUE WITH THE BARBED SUTURE BREAKING AT THE NEEDLE DURING USAGE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056576 ↗
• MalfunctionMar 19, 2026Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639276 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. WHEN THE SURGEON WENT TO USE SXPP1B410, THE FIXATION LOOP WAS BROKEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551375 ↗
• MalfunctionMar 9, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A, OPEN TAH ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON WAS CLOSING THE SUBCUTANEOUS LAYER USING THE BARBED SUTURE WITH A CT-1 NEEDLE AND THE NEEDLE BROKE IN HALF. THE SURGEON WAS ABLE TO RECOVER THE HALF OF THE NEEDLE THAT BROKE OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550710 ↗
• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535378 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS BROKEN WHEN THE SURGEON SEW THE TISSUE. 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 24469226 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL TUMOR SURGERY 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 CERVICAL STUMP. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE LOT OF IP IS UNAVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402487 ↗
• MalfunctionJan 22, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN (B)(6) 2025 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 REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147516 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24084657 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC EXAMINATION, LAPAROSCOPIC TRANSABDOMINAL TOTAL HYSTERECTOMY, LAPAROSCOPIC BILATERAL OOPHORECTOMY AND SALPINGECTOMY, LAPAROSCOPIC PELVIC ADHESIOLYSIS DUE TO CINIII ON (B)(6) 2025 AND A BARBED SUTURE WAS USED TO SUTURE THE VAGINA. THE PATIENT WAS DISCHARGED SMOOTHLY AFTER THE SURGERY. POST-OP, THE PATIENT HAD INFLAMMATION AND POOR WOUND HEALING. THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP VISIT 94 DAYS AFTER SURGERY, AND UNDER COLPOSCOPY, EXPOSED SUTURE WAS FOUND AT THE VAGINA STUMP, AS WELL AS POLYPOID GROWTHS. IT WAS STATED THAT THE SUTURE LEAD TO POOR HEALING OF VAGINAL STUMP, AND LOCAL INFLAMMATION LEAD TO GRANULOMATOUS HYPERPLASIA. VAGINAL MEDICATION WAS GIVEN AND REGULAR FOLLOW-UP VISITS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Impaired Healing; Inflammation; Pocket Erosion

  MAUDE report 24034624 ↗
• MalfunctionJan 6, 2026Positioning Failure

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED RADICAL RESECTION FOR COLON CANCER PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE SURGERY, THE DOCTOR USED BARBED SUTURE SXMP1B427, TO REINFORCE THE ANASTOMOTIC SITE, BUT THE SUTURE BROKE. TWO BARBED SUTURES SXPP1B410 WERE USED FOR SUBCUTANEOUS SUTURING, BUT THE BARB NON-ENGAGEMENT IN TISSUE AND THE SUTURES COULD BE EXTRACTED FROM THE TISSUE. 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 23974472 ↗