Duo-Flow® XTP116IJSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884908059144), received between Jun 29, 2021 and Jun 29, 2021 — classified as 2 deaths.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AORTIC VALVE REPLACEMENT AND CORONARY BYPASS SURGERY ON (B)(6) 2021. POST OPERATIVELY IN THE CRITICAL CARE UNIT, HE PRESENTED WITH DETERIORATION OF KIDNEY FUNCTION. ON (B)(6) 2021 A PERCUTANEOUS DIALYSIS CATHETER WAS INSERTED THROUGH ULTRASOUND-GUIDED RIGHT INTERNAL JUGULAR VEIN, TO PERFORM DIALYSIS. AFTER INSERTION, PATIENT SITS DOWN. HEMODYNAMICALLY AND RESPIRATORY STABLE. WHEN STARTING DIALYSIS, AIR ASPIRATION WAS OBSERVED THROUGH ONE OF THE LIGHTS. ON CHEST RADIOGRAPHY, THE CATHETER APPEARS TO BE NORMALIZED, SO IT WAS DECIDED TO REMOVE IT AND INSERT A NEW ONE. AFTER REMOVING THE CATHETER, THE PATIENT PRESENTED RAPID CLINICAL DETERIORATION, WITH CARDIAC ARREST. RESUSCITATION MANEUVERS AND EMERGENT STERNOTOMY REVEALED THE EXISTENCE OF A LARGE HEMATOMA IN THE RIGHT HEMOTHORAX. REGULATED SURGICAL REVISION WAS PERFORMED, NO VASCULAR LESION WAS OBSERVED, NOR NEW BLEEDING. UNFAVORABLE SUBSEQUENT EVOLUTION, WITH CEREBRAL HYPOXIA, AND DEATH TWO DAYS LATER.

  Patient problems: Cardiac Arrest; Hematoma

  MAUDE report 12087683 ↗
• DeathJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRITICAL PATIENT, SEDATED AND ON MECHANICAL VENTILATION, WITH MEDIASTINAL DRAINAGE. ULTRASOUND-GUIDED PUNCTURE IN THE LEFT INTERNAL JUGULAR VEIN. INSERTION OF CATHETER WITHOUT APPARENT INCIDENTS. VENOUS BLOOD REFLUX THROUGH BOTH LUMENS OF THE CATHETER. SEALED WITH 1% HEPARIN. MOBILIZATION AND HYGIENE OF THE PATIENT IS CARRIED OUT. TWO HOURS LATER, BEFORE STARTING THERAPY, MASSIVE BLEEDING FROM THE MEDIASTINAL DRAINS, WITH CARDIAC ARREST. EMERGING STERNOTOMY, INNOMINATE VEIN LACERATION IS OBSERVED.

  Patient problems: Cardiac Arrest; Laceration(s)

  MAUDE report 12086590 ↗