ULTRABRAID 72200886Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010587657), received between Aug 24, 2022 and Jun 2, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT SIDE HIP REPLACEMENT ON (B)(6) 2022; IN WHICH AN ULTRABRAID SUTURE WAS USED TO SUTURE AND REPAIR THE LIGAMENTS AROUND THE JOINT. THE POSTOPERATIVE WOUND HEALED WELL. ON (B)(6) 2023, THE PATIENT EXPERIENCED REDNESS AND SWELLING OF THE INCISION, WHICH PERSISTED FOR A LONG TIME AFTER INCISION AND DRAINAGE; THEREFORE THE PATIENT ENTERED THE HOSPITAL AGAIN FOR TREATMENT ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT UNDERWENT INCISION DEBRIDEMENT, EXPLORATION, AND FOREIGN BODY REMOVAL SURGERY. DURING THE SURGERY, IT WAS FOUND THAT THE FISTULA WAS RELATED TO THE SUTURE OF THE DEVICE. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Fistula; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 17050923 ↗
• MalfunctionSep 9, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING SET UP, A SUTURE #2 ULTRABRAID HAD HOLES IN THE PRODUCT´S PACKAGE, OBSERVED BY THE NURSE BEFORE USAGE. THERE WAS A BACK-UP DEVICE AVAILABLE AND NON-SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397328 ↗
• MalfunctionAug 24, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE ULTRABRAID WHITE SUTURE PACKAGE WAS UNSEALED. NO CASE REPORTED, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287870 ↗