STRATAFIX SXPP1A432Recalls & reported problems
Ethicon, LLC · Violet Antibacterial Polydioxanone, Knotless Tissue Control Device · Class 2 · Implant
Quick summary
This Ethicon Stratafix absorbable barbed suture is used to close tissue without knots. Reports mostly describe the suture breaking or the needle pulling off during surgery, with another suture used to finish the procedure. There are 26 reports mentioning this identifier, with no deaths and no injuries. No recalls name this device, and reports rose recently, with 13 in the last year compared with 3 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10705031245327), received between Jul 16, 2021 and Sep 29, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Break” (21 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.
Reports received per month
Most reported problems
Device problems
- Break21
- Material Separation7
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937143 ↗MalfunctionSep 23, 2026Break
It was reported that a patient underwent an unknown procedure on an unknown date 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. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872806 ↗MalfunctionAug 19, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331019 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50305324 ↗MalfunctionJun 1, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A TIBIAL FIXATION SURGERY PROCEDURE 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. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348615 ↗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 PULLING OFF SUTURE NEEDLE HAPPENED IN THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164375 ↗MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND A BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING 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 25164135 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. 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 24059975 ↗MalfunctionJan 13, 2026Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A WOUND CLOSURE PROCEDURE IN (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 WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24057907 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT WOUND CLOSURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE SUTURE BROKE WHEN SEWING IN THE SURGERY. 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 24057317 ↗MalfunctionDec 31, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL ORTHOPEDICS 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. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935494 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL LAPAROSCOPIC MYOMECTOMY PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING SURGERY THE NEEDLE TIP BROKE DURING SEWING. WITH THE HELP OF AN X-RAY, IT LOOK FOR THE BROKEN TIP AROUND 30 MINUTES, BUT FINALLY FAILED TO FIND IT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 23692130 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW 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 23691988 ↗MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE JOINT REPLACEMENT SURGERY 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 WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23682142 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL ORTHOPEDIC SURGERY 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 SPINAL ORTHOPEDIC 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 23647614 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTOTAL HYSTERECTOMY SURGERY 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 SUBTOTAL HYSTERECTOMY 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 23647536 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTERECTOMY SURGERY 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 21936497 ↗MalfunctionApr 30, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A SUBTOTAL HYSTERECTOMY 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 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 21935394 ↗MalfunctionDec 27, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UTERINE FIBROIDS, OVARIAN TUMOR TORSION SURGERY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, DOCTOR PERFORMED SURGERY ON A PATIENT WITH UTERINE FIBROIDS OR OVARIAN TUMOR TORSION. AFTER REMOVING THE FIBROIDS AND SUTURING THE TUMOR CAVITY, THE SUTURE BROKE. THE PATIENT WAS PROMPTLY TREATED WITH A NEW SUTURE. THIS EVENT CAUSED A DELAY IN THE STITCHING TIME, SIGNIFICANTLY INCREASING THE RISK. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21028999 ↗MalfunctionJul 22, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. 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 19801995 ↗MalfunctionJul 22, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL ABDOMINAL HYSTERECTOMY ON (B)(6) 2024 AND A BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN SEWING. 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 19801361 ↗MalfunctionAug 2, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 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 17441811 ↗MalfunctionJul 26, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A SPINAL PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT 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 17397683 ↗MalfunctionMar 29, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE VAGINAL STUMP AT THE FIRST STITCH. 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 16637573 ↗MalfunctionApr 27, 2022Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ORTHOPEDIC PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE FIXATION TAB CAME OFF THE SUTURE DURING CONTINUOUS SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14220176 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.