STRATAFIX SXPP1A428Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031245020), received between Nov 24, 2025 and May 19, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE SURGEON WAS REINFORCING SILASTIC IMPLANT IN THE LARYNX WITH APPROPRIATE NEEDLE AND NEEDLE DRIVER. AS THE IMPLANT WAS BEING SUTURED IN PLACE, THE EYE OF THE NEEDLE BROKE. SURGEON MADE TEAM AWARE, SURGEON WAS ABLE TO REMOVE X 3 PIECES. 2 PIECES WERE REMOVED FROM THE PATIENT LARYNX VIA GRASPER, AND 1 PIECE WAS REMOVED FROM THE NEEDLE DRIVER VIA MAGNET. COMPARED PIECES ON TELFA, UPON INSPECTION IT WAS DETERMINED ALL PIECES WERE RETRIEVED. THERE WAS NO BLEEDING THROUGHOUT THE REMOVAL PROCESS. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 25216117 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR WOUND CLOSING OF THE GROIN AREA. POST-OP, THE PATIENT DEVELOPED AN INFECTION. THE SAME PHENOMENON OCCURRED IN A FEW CASES. THE PERIOD OF USE AND THE DOCTOR¿S NAME ARE UNKNOWN AT THIS TIME ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Ischemia; Necrosis; Unspecified Infection; Wound Dehiscence

  MAUDE report 23638091 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND A BARBED SUTURE WAS USED FOR WOUND CLOSING OF THE GROIN AREA. POST-OP, THE PATIENT DEVELOPED AN INFECTION. THE SAME PHENOMENON OCCURRED IN A FEW CASES. THE PERIOD OF USE AND THE DOCTOR¿S NAME ARE UNKNOWN AT THIS TIME ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hernia; Ischemia; Necrosis; Unspecified Infection; Wound Dehiscence

  MAUDE report 23638073 ↗