STRATAFIX SXPP1A413Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031245044), received between Mar 12, 2019 and Sep 30, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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.

• MalfunctionSep 30, 2026Material Separation

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948615 ↗
• MalfunctionAug 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50300750 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC LIVER RESECTION ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR LIVER RETRACTION. POST-OP, THE PATIENT HAD A PNEUMOTHORAX. THE SURGEON INITIALLY ACCOUNTED THE PNEUMOTHORAX TO THE USE OF THE BARBED SUTURE, AS THE LIVER RETRACTION METHOD REQUIRES THE SUTURE TO BE FIXATED TO THE PERITONEUM / DIAPHRAGM, WHICH COULD POTENTIALLY CAUSE A DEFECT IN THE DIAPHRAGM. CLARIFICATION QUESTIONS WERE ASKED, SUCH AS HOW CAN A PNEUMOTHORAX OCCUR AND WAS THERE REALLY A DEFECT IN THE DIAPHRAGM. THE SURGEON CLARIFIED THAT THERE WAS NO DEFECT FOUND AND CONCLUDED IT MIGHT NOT HAVE BEEN RELATED TO THE BARBED SUTURE. HOWEVER, THERE ARE STILL SOME CONCERNS REGARDING THIS TECHNIQUE AFTER THIS INCIDENT. THE PATIENT HAS HEALED AND WAS DISCHARGED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Pneumothorax

  MAUDE report 17405696 ↗
• MalfunctionMar 17, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND BARBED SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE DISCONNECTED FROM SUTURE DURING ENTERING IT THROUGH THE TROCAR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792026 ↗
• MalfunctionMar 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC INGUINAL HERNIA PROCEDURE ON AN UNKNOWN DATE IN 2019 AND BARBED SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE DURING CLOSURE OF THE PERITONEUM. THE NEEDLE WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8412635 ↗