Swan Ganz Catheter 111NX7PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103198430), received between Aug 27, 2024 and May 9, 2025 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 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 9, 2025Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings; Fluid/Blood Leak; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH A SWAN GANZ CATHETER, THE CLINICIAN HAD TROUBLE OBTAINING ACCURATE READINGS. UPON INSPECTION OF THE SWAN GANZ CATHETER THERE WAS A CRACK FOUND IN THE BLUE PROXIMAL TUBING THAT WAS ATTACHED TO THE MONITOR. IT WAS NOTED THAT FLUID LEAKED FROM THE CATHETER WHEN ATTEMPTING TO OBTAIN CARDIAC OUTPUT VALUES. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995319 ↗
• MalfunctionMay 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED BEFORE PATIENT USE WITH A PULMONARY ARTERY CATHETER, THE INTRODUCER CATHETER TIP CRACKED AND ALL THE CONTINUOUSLY INFUSING MEDICATIONS LEAKED OUT. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. THE INFORMATION WAS PROVIDED THROUGH A VOLUNTARY MEDWATCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995312 ↗
• DeathAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM AN ANONYMOUS FACILITY THAT A PATIENT DIED DURING A RIGHT HEART CATHETERIZATION PRIOR TO A CARDIOMEMS IMPLANT PROCEDURE. THE PHYSICIAN INSERTED A MEDTRONIC 0.18 NITREX GUIDEWIRE AND ADVANCED THE GUIDEWIRE TO THE PULMONARY ARTERY AND USED A SWAN GANZ CATHETER OVER THE GUIDEWIRE. THE PATIENT COUGHED A FEW TIMES, AND THE RIGHT HEART CATHETERIZATION WAS CONTINUED. THE PATIENT THEN EXPERIENCED HEMOPTYSIS AND RESUSCITATION WAS ATTEMPTED AS THE PATIENT WAS DETERIORATING. A THORACOTOMY WAS COMPLETED IN AN ATTEMPT TO STOP THE BLEEDING, BUT THE PATIENT DIED IN THE CATH LAB. CARDIOMEMS SENSOR WAS NOT OPENED OR INSERTED INTO THE BODY. CAUSE OF DEATH WAS NOT SPECIFICALLY IDENTIFIED, BUT THE PHYSICIAN BELIEVED THAT THERE WAS A PERFORATION, HOWEVER ONE COULD NOT BE IDENTIFIED. IT WAS NOTED THAT THE PATIENT ALSO EXPERIENCED CARDIAC ARREST, BLEEDING, AND RESPIRATORY ARREST.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Respiratory Arrest

  MAUDE report 20075781 ↗