STRATAFIX SXPP1A421Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031245341), received between Jul 6, 2022 and May 23, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN BOWEL WALL REPAIR ON (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT WAS DISCHARGED ON THE FOURTH DAY AFTER THE PROCEDURE, BUT ON THE TENTH DAY AFTER THE PROCEDURE, HE RETURNED TO THE EMERGENCY ROOM IN SEVERE PAIN AND HAD TO UNDERGO FURTHER SURGERY. THIS TIME, LAPAROSCOPICALLY, THEY DISCOVERED AN INTESTINAL OBSTRUCTION CAUSED BY THE BARBED SUTURE GETTING CAUGHT IN A LOOP OF BOWEL. THE RE-OPERATION WAS SUCCESSFUL, BUT THE DOCTOR NEEDS TO KNOW WHAT HE DID TECHNICALLY WRONG WITH THE CLOSURE TO CAUSE THIS OBSTRUCTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Adhesion(s); Fluid Discharge; Obstruction/Occlusion; Pain; Unspecified Infection

  MAUDE report 22081102 ↗
• InjuryNov 14, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HERNIA OPERATION ON AN UNKNOWN DATE AND BARBED SUTURE WAS USED. THE NEEDLE FIRST BENT AND THEN BROKE IN TO THE PATIENTS TISSUE. THEY NEEDED X-RAY TO LOCATE THE NEEDLE AND FINALLY REMOVED IT IN OPEN SURGERY. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20692350 ↗
• InjuryApr 27, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A Y BYPASS ON (B)(6) 2023 AND A BARBED SUTURE WAS USED. THE FOLLOWING WAS REPORTED: THERE WAS A RUPTURE OF THE THREAD. A DISSECTION OF THE SUBMUCOSAL TISSUE BY THE THREAD PASSAGE THAT IS A LITTLE TOO THICK, CAUSING INTRALUMINAL BLEEDING AT THE LEVEL OF THE GASTRIC SIDE OF THE ANASTOMOSIS, BLOOD CLOT A LARGE HEMATOMA IN THE GASTROJEJUNAL ANASTOMOSIS CALIBRATED AT 2CM, HIGH OCCLUSION. THERE WAS A COMPLETE STENOSIS OF THE GASTROJEJUNAL ANASTOMOSIS WITH OCCLUSION. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM TO PERFORM A SURGICAL REVISION FOR COMPLETE DYSPHAGIA. THE SURGEON REDID THE ANASTOMOSES WITH A DIFFERENT DEVICE, A ROUND WIRE THIS TIME. THE SUITES WERE SIMPLE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Dysphagia/ Odynophagia; Hematoma; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Unspecified Tissue Injury; Vomiting

  MAUDE report 16825397 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940754 ↗
• MalfunctionJul 6, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HERNIA REPAIR PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940673 ↗