ETHICON U10TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031051034), received between May 1, 2019 and Sep 28, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A NEWBORN UNDERWENT UMBILICAL CORD TYING ON AN UNKNOWN DATE AN SUTURE WAS USED. WHEN USING THE TAPE ON THE UMBILICAL CORD, IT CUTS CAUSING BLEEDING FROM IT. LIKE THE KNOT IS BEING RELEASED EASILY AND IT LEAVES THE CORD AND BEGAN TO BLEED. DESPITE MAKING 3 KNOTS OF THE HILADILLO TO CUT THE UMBILICAL CORD, THE PATIENT HAS ABUNDANT BLEEDING FROM IT. IT SHOULD BE NOTED THAT THESE PROCEDURES OF LIGATION AND TYING OF THE UMBILICAL CORD, IN THESE CASES, WERE PERFORMED BY THE PEDIATRICIANS AND RESIDENTS OF NEONATOLOGY, IN THE NEWBORN. ADDITIONAL INFORMATION WAS REQUESTED. THE CASE WAS DISCHARGED WITHOUT KNOWN SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17836122 ↗
• MalfunctionSep 28, 2023Break; Break

  IT WAS REPORTED THAT A NEWBORN UNDERWENT UMBILICAL CORD TYING ON AN UNKNOWN DATE AN SUTURE WAS USED. WHEN USING THE TAPE ON THE UMBILICAL CORD, IT CUTS CAUSING BLEEDING FROM IT. LIKE THE KNOT IS BEING RELEASED EASILY AND IT LEAVES THE CORD AND BEGAN TO BLEED. DESPITE MAKING 3 KNOTS OF THE HILADILLO TO CUT THE UMBILICAL CORD, THE PATIENT HAS ABUNDANT BLEEDING FROM IT. IT SHOULD BE NOTED THAT THESE PROCEDURES OF LIGATION AND TYING OF THE UMBILICAL CORD, IN THESE CASES, WERE PERFORMED BY THE PEDIATRICIANS AND RESIDENTS OF NEONATOLOGY, IN THE NEWBORN. ADDITIONAL INFORMATION WAS REQUESTED. THE CASE WAS DISCHARGED WITHOUT KNOWN SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17836115 ↗
• InjuryJul 27, 2022Break; Break

  IT WAS REPORTED THAT A NEWBORN UNDERWENT UMBILICAL CORD TYING ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN USING THE TAPE ON THE UMBILICAL CORD, IT CUTS CAUSING BLEEDING FROM IT. LIKE THE KNOT IS BEING RELEASED EASILY AND IT LEAVES THE CORD AND BEGAN TO BLEED. DESPITE MAKING 3 KNOTS OF THE HILADILLO TO CUT THE UMBILICAL CORD, THE PATIENT HAS ABUNDANT BLEEDING FROM IT. IT SHOULD BE NOTED THAT THESE PROCEDURES OF LIGATION AND TYING OF THE UMBILICAL CORD, IN THESE CASES, WERE PERFORMED BY THE PEDIATRICIANS AND RESIDENTS OF NEONATOLOGY, IN THE NEWBORN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15118137 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A NEWBORN UNDERWENT AN UMBILICAL CORD PROCEDURE ON AN UNKNOWN DATE AND COTTON UMBILICAL SUTURE WAS USED. THE NURSE PLACED AN EMERGENT CALL WITH A NEWLY BORN INFANT IN THE ARMS AND INFANT WAS CYANOTIC, MODERATE BLEEDING BY UMBILICAL CORD OBSERVED IN THE DIAPER. THE NURSE IMMEDIATELY REPORTED THIS TO THE PEDIATRIC DEPARTMENT AND PHYSICIAN ATTENDING THE CALL ASSESSED THE NEONATE AND SAW THAT THE LEAGUE THAT HAS THE NEWBORN IS FIXED IN THE CORD BUT STILL DOES NOT ACHIEVE HEMOSTASIS. THE BLEEDING PERSISTED AND PHYSICIAN PROCEEDED TO LINK THE SUTURE WITH NON-ABSORBABLE SUTURE. THE PHYSICIAN CALLED A PEDIATRICIAN WHO ORDERED HOSPITALIZATION OF THE NEONATE IN THE NEONATAL INTERMEDIATE CARE AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss; Not Applicable

  MAUDE report 8570668 ↗