STRATAFIX SXPP2B411Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031464537), received between Jul 13, 2023 and Sep 24, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885346 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CAESAREAN SECTION ON (B)(6) 2026 AND A BARBED SUTURE WAS USED FOR CLOSING THE UTERINE MUSCLE LAYER. POST-OP, AN INFECTION OCCURRED NEAR THE UTERINE WOUND AFTER THE SURGERY. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. TREATMENTS (REMOVAL OF SUTURES, CLEANING AND RE-SUTURING) WERE PERFORMED, AND THE PATIENT IS CURRENTLY RECEIVING TREATMENT. THE DOCTOR'S COMMENT WAS THAT IT WAS UNKNOWN WHETHER THE SUTURES WERE THE DIRECT CAUSE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 25082055 ↗
• MalfunctionApr 8, 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 BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE EASILY DURING USE. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24821658 ↗
• MalfunctionAug 6, 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 TO SALES REP BY THE STAFF THAT THE NEEDLE POPPED OFF THE BIDIRECTIONAL STRATAFIX MID CLOSURE. OPENED A NEW SINGLE ARM STRATAFIX TO FINISH. NO SURGICAL DELAY WAS THERE. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730132 ↗
• MalfunctionAug 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17573800 ↗
• MalfunctionJul 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING SURGERY, WHEN THE SURGEON PUT THE FIRST STITCH AND THEN PULLED THE NEEDLE WITH A NEEDLE HOLDER, THE NEEDLE WAS DETACHED FROM THE SUTURE. THE PRODUCT WAS USED ON UTERUS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17419527 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UTERINE MYOMETRIUM PROCEDURE ON (B)(6) 2023 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING THE UTERINE MYOMETRIUM, THE NEEDLE WAS DETACHED FROM THE SUTURE WHEN THE NEEDLE WAS PULLED WITH A NEEDLE HOLDER AFTER PENETRATION. THE SURGEON SAID THAT MAYBE THE FORCE AGAINST THE NEEDLE WAS TOO STRONG. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316341 ↗