STRATAFIX SXPP1B409Recalls & reported problems
Ethicon, LLC · Knotless Tissue Control Device, Violet Unidirectional (Antibacterial) Synthetic Absorbable Device · Class 2 · Implant
All models of STRATAFIX (181)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon STRATAFIX barbed suture is a knotless, absorbable violet surgical suture used to close tissue without tying knots. The 48 reports mostly describe the suture breaking during surgery, the barbs not holding so the suture slipped back or unraveled while a wound was being closed, and the needle detaching from the suture. Six reports involve injuries; no deaths were reported. No recalls name this device.
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
- 49
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705031236127), received between Mar 7, 2018 and Sep 16, 2026 — classified as 6 injuries, 43 malfunctions.
The most frequently reported specific device problem is “Break” (27 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.
Reports received per month
Most reported problems
Device problems
- Break27
- Positioning Failure13
- Material Separation5
- Adverse Event Without Identified Device or Use Problem2
- Defective Component2
- Positioning Problem2
- Component Misassembled1
- Failure To Adhere Or Bond1
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient5
- Wound Dehiscence3
- Insufficient Information2
- Not Applicable2
- Unspecified Infection2
- Sepsis1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50794380 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. BARBED SUTURE BREAKAGE WHILE DOING THE SURGERY. THERE WAS A 25 MINUTE SURGICAL DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820193 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. BARBED SUTURE BREAKAGE WHILE DOING THE SURGERY. THERE WAS A 25 MINUTES SURGICAL DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820192 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. BARBED SUTURE BREAKAGE WHILE DOING THE SURGERY. THERE WAS A 25 MINUTES SURGICAL DELAY REPORTED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820191 ↗MalfunctionNov 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE STRATAFIX SUTURE BROKE WHILE THE WOUND WAS BEING CLOSED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647412 ↗MalfunctionNov 27, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE IN 2024 AND BARBED SUTURE WAS USED. DURING A TLH AND WHEN CLOSING THE VAGINAL VAULT SURGEON FOUND THAT THE BARBS WEREN¿T HOLDING AND ACTUALLY THE SUTURE SLIPPED BACK. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20796156 ↗MalfunctionNov 26, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDUR EON (B)(6) 2024 AND SUTURE WAS USED. WHILE SUTURING THE NEEDLE GETS DETACHED FROM THE SWAGING END. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20787033 ↗MalfunctionOct 22, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC VAGINAL HYSTERECTOMY PROCEDURE IN (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE SURGEON CLOSING VAULT WITH STRATAFIX & AT TERMINATION OF SUTURING THE VAULT JUST 'UNRAVELED'. IT WAS LIKE THERE WAS NO ANCHORS ON THE SUTURE. SURGEON COMPLETED CLOSURE OF THE VAULT WITH AN UNINTERRUPTED VICRYL SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Wound Dehiscence
MAUDE report 20505696 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937809 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937806 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937799 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937798 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937797 ↗MalfunctionAug 8, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED A PATIENT UNDERWENT A LAP MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. AS PER HCP SUTURE IS NOT SUPPORTING HOLDING STRENGTH DURING MYOMECTOMY PROCEDURE. BARB NOT HOLDING TISSUE PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937789 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURES HAD BROKEN DURING SURGERY. THERE WAS NO DELAY DUE TO THE EVENT, AND THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100956 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURES HAD BROKEN DURING SURGERY. THERE WAS NO DELAY DUE TO THE EVENT, AND THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100215 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURES HAD BROKEN DURING SURGERY. THERE WAS NO DELAY DUE TO THE EVENT, AND THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100176 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURES HAD BROKEN DURING SURGERY. THERE WAS NO DELAY DUE TO THE EVENT, AND THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100156 ↗MalfunctionApr 12, 2024Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURES HAD BROKEN DURING SURGERY. THERE WAS NO DELAY DUE TO THE EVENT, AND THE FRAGMENTS GENERATED WERE EASILY REMOVED WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19100152 ↗InjuryMar 20, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE NEEDLE BROKE DURING THE PROCEDURE. THE CASE WAS MOVED TO AN OPEN PROCEDURE. THE PROCEDURE WAS EXTENDED BY 50 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18944698 ↗InjuryMar 20, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE NEEDLE BROKE DURING THE PROCEDURE. PIECES MANAGED TO RETRIEVE WITHIN LAP MODE. THE NEEDLE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE SURGERY WAS DELAYED 20 MINUTES DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944697 ↗InjuryMar 20, 2024Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOMECTOMY PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. THE SUTURE NEEDLE BROKE DURING THE PROCEDURE. XRAY HAD TO BE USED AND PROCEDURE MOVED TO OPEN. THE PROCEDURE WAS EXTENDED BY 2 HOURS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18943077 ↗MalfunctionJan 31, 2024Positioning Failure; Positioning Failure
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VAGINAL PROCEDURE ON (B)(6) 2024 AND BARBED SUTURE WAS USED. DURING THE CLOSURE OF THE VAGINAL DOME, THE SURGEON STATES THAT THE SUTURE DEVICE DID NOT ANCHOR IN THE TISSUE, SHOWING THAT THE THREAD DOES NOT HAVE ANCHORS FORMED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18615772 ↗MalfunctionJan 29, 2024Positioning Failure; Defective Component; Positioning Failure; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR REPORTS THAT THE SPIRAL STRATAFIX DEVICE HAS NO ANCHORS THAT ALLOW IT TO HOLD ON TO THE TISSUE "IT'S LIKE IT'S USING A NORMAL PDS". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18594394 ↗MalfunctionJan 29, 2024Positioning Failure; Defective Component; Positioning Failure; Defective Component
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 05/01/2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE DOCTOR REPORTS THAT THE SPIRAL STRATAFIX DEVICE HAS NO ANCHORS THAT ALLOW IT TO HOLD ON TO THE TISSUE "IT'S LIKE IT'S USING A NORMAL PDS". NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18594392 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
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- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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