STRATAFIX SXPP1B111Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031236288), received between Aug 28, 2019 and Feb 25, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE IN 2026 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6), THE SUTURE DETACHMENT HAS OCCURRED. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. 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 24445070 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A MASTECTOMY FOR BREAST CANCER, THE SUTURE WAS BROKEN EASILY DURING USE. THE PRODUCT WAS USED ON THE DERMIS. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097686 ↗
• MalfunctionJul 27, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE LOOP CAME OFF DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230163 ↗
• MalfunctionMar 5, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY AND THE BARBED SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THE SUTURE DID NOT HAVE A LOOP. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED SAMPLE IT WAS FOUND THAT THE LOOP WAS BUSTED AND CONSEQUENTLY THE SECOND LOOP WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9794679 ↗
• MalfunctionAug 28, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE LOOP OF THE SUTURE CAME OFF DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON EVALUATION OF DEVICE RETURNED, THE FIRST LOOP WAS BUSTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941779 ↗