STRATAFIX SXPP1A440Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031245181), received between Nov 17, 2023 and Sep 24, 2026 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on (b)(6) 2026 and a barbed suture was used. Post-op, the patient developed an abdominal incisional hernia. It was stated that the situation will be monitored going forward, and depending on the condition, surgical repair may be necessary. The patient is currently under observation. It was opined by the doctor that they are unsure of the exact cause but commented that weight gain after the surgery might be a contributing factor. Additional information was requested.

  Patient problems: Hernia

  MAUDE report 50881817 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used. Six months post-op, the patient developed an abdominal incisional hernia which the patient was very concerned about, so a repair surgery was performed. The doctor commented that the cause was weight gain after the surgery, and that there might also be some technical issues involved. Additional information was requested.

  Patient problems: Hernia

  MAUDE report 50881816 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN SPINE PROCEDURE ON (B)(6) 2026 AND BARBED SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WHO WAS USING SYMMETRIC IN A SPINE CASE AND THE SUTURE BROKE DURING THE SECOND PASS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299549 ↗
• MalfunctionSep 11, 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 ONE OF THEIR SURGEONS WAS USING BARBED SUTURE IN A SURGERY AND THE NEEDLE CAME OFF OF THE SUTURE DURING THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025439 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CUTANEOUS URETEROSTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND DEHISCENCE OF FASCIAL CLOSURE. IT RIPPED THE FASCIA, ALMOST LIKE TOO MUCH TENSION THAT IT RIPPED THROUGH. SURGEON HAS USED THIS SUTURE FOR 4 YEARS WITHOUT ISSUES UNTIL NOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22312555 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CUTANEOUS URETEROSTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND DEHISCENCE OF FASCIAL CLOSURE. IT RIPPED THE FASCIA, ALMOST LIKE TOO MUCH TENSION THAT IT RIPPED THROUGH. SURGEON HAS USED THIS SUTURE FOR 4 YEARS WITHOUT ISSUES UNTIL NOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22312553 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CUTANEOUS URETEROSTOMY PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE PATIENT DEVELOPED A WOUND DEHISCENCE OF FASCIAL CLOSURE. IT RIPPED THE FASCIA, ALMOST LIKE TOO MUCH TENSION THAT IT RIPPED THROUGH. SURGEON HAS USED THIS SUTURE FOR 4 YEARS WITHOUT ISSUES UNTIL NOW. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Wound Dehiscence

  MAUDE report 22312552 ↗
• MalfunctionMay 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC HERNIA REPAIR CASE PROCEDURE ON (B)(6) 2025 AND A BARBED SUTURE WAS USED. THE SURGEON SAID THE SUTURE SPLIT IN HALF WHILE CLOSING THE FASCIA USING A ROBOTIC INSTRUMENT AND HAD TO REDO THE FASCIAL CLOSURE. IN AN OPEN CASE, SURGEON SAID THE BARBED EDGES STRIPPED HER GLOVES AND SHE COULD FEEL THE ABRASIVE NATURE OFF SUTURE ON THE TISSUE. PROCEDURES WERE COMPLETED WITHOUT ANY SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996810 ↗
• InjuryNov 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. ON (B)(6) 2023, THE PATIENT FELL DURING REHABILITATION AND THE WOUND OPENED BY ACCIDENT AND WAS RE-SUTURED. THE SURGEON SAID THIS WAS NOT A PRODUCT DEFECT. THE PATIENT IS IN THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 18165687 ↗