Symphony™ Catheter SYMPHONY24FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850032079129), received between Jan 6, 2026 and Jun 1, 2026 — 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY EMBOLISM (PE) PROCEDURE, THE SYMPHONY 24F WAS ADVANCED THROUGH THE HEART TO THE LEFT PULMONARY ARTERY AND AFTER THE FIRST PASS OF 6 PULSES, THE PATIENT BEGAN TO COUGH UP BLOOD. THE DEVICE WAS REMOVED, AND THE THROMBECTOMY PROCEDURE WAS ABORTED. DESPITE RESUSCITATIVE EFFORTS, THE PATIENT EXPIRED DUE TO HYPOVOLEMIA. A PERFORATION OF THE LEFT MAIN PULMONARY ARTERY WAS IDENTIFIED AFTER THE PATIENT HAD CODED. THE CAUSE OF THE PERFORATION COULD NOT BE DEFINITIVELY DETERMINED AND MAY HAVE BEEN RELATED TO TRAUMA ASSOCIATED WITH MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR)OR POTENTIALLY CATHETER-RELATED TRAUMA. IT WAS INDICATED THAT COILING OF THE PULMONARY ARTERY (PA) WAS ATTEMPTED AFTER THE PATIENT CODED; HOWEVER, THE PATIENT EXPIRED BEFORE THE COILING PROCEDURE COULD BE COMPLETED. AT THIS TIME, IT REMAINS UNCLEAR WHETHER THE DEVICE CONTRIBUTED TO THE ADVERSE EVENT. THE PHYSICIAN STATED THE CLINICAL OUTCOME WOULD HAVE BEEN THE SAME REGARDLESS OF DEVICE USE.

  Patient problems: Perforation of Vessels

  MAUDE report 25353603 ↗
• DeathJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PULMONARY EMBOLISM (PE) THROMBECTOMY PROCEDURE, THE PHYSICIAN NAVIGATED A PIGTAIL CATHETER TO MAIN PULMONARY ARTERY (PA) AND PERFORMED POWER INJECTION CONFIRMING THE CLOT LOCATION TO BE BILATERAL. THIRD PARTY DEVICES WERE USED AND SYMPHONY 24F WAS ADVANCED TO THE RIGHT PULMONARY ARTERY (PA). ONE PASS WAS PERFORMED WITH THE SYMPHONY 24F CATHETER WHICH RETRIEVED SIGNIFICANT CLOT. AT THIS POINT, THE PATIENT BEGAN COUGHING, HOWEVER NO HEMOPTYSIS WAS NOTED. THE SYMPHONY 24F WAS REPOSITIONED TO MAIN PULMONARY ARTERY (PA), AND THE PATIENT BEGAN TO DECOMPENSATE. THE PHYSICIAN REINSERTED THE DILATOR, ADVANCED THIRD-PARTY WIRE, AND USED SYMPHONY 24F TO THE OSTIUM OF LATERAL BRANCH. A PASS WAS PERFORMED HOWEVER NO CLOT WAS RETRIEVED. SYMPHONY 16F WAS THEN USED AND THE PATIENT CONTINUED TO DECOMPENSATE. CHEST COMPRESSIONS WERE INITIATED. THE PHYSICIAN THEN USED SYMPHONY 16F, BUT NO CLOT WAS RETRIEVED. THROMBECTOMY PROCEDURE WAS STOPPED, AND A CODE WAS CALLED. POWER INJECTION WAS PERFORMED WHILE THE STAFF CONTINUED WITH CHEST COMPRESSIONS. A LARGE CLOT WAS NOTED IN THE RIGHT PULMONARY ARTERY. THE PHYSICIAN USED SYMPHONY 24F TO THE RIGHT SIDE AS CHEST COMPRESSIONS C

  Patient problems: Embolism/Embolus

  MAUDE report 23986563 ↗