Symphony™ Catheter SYMPHONY16FRecalls & reported problems
Imperative Care, Inc. · 16F Symphony™ Catheter w/ Dilator · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850032079112), received between Nov 20, 2024 and Nov 20, 2024 — classified as 1 death.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE EVENING OF (B)(6) 2024, A 77-YEAR-OLD-MALE PATIENT ARRIVED AT THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED. THE CT SCAN SHOWED THAT THE PATIENT'S RIGHT VENTRICLE/ LEFT VENTRICLE (RV/LV) RATIO WAS A 1.4. THE HOSPITAL'S ON-CALL INTERVENTIONAL RADIOLOGIST WAS CONSULTED REGARDING THE CT SCAN RESULTS. CT SCAN SHOWED THE ENTIRE RIGHT LUNG WAS OCCLUDED PROXIMAL TO THE TRUNCUS ANTERIOR. THE PATIENT'S LEFT LEG WAS NOTED TO BE SWOLLEN, SO AT AN UNSPECIFIED DATE AND TIME A DOPPLER ULTRASOUND WAS PERFORMED. ON THE MORNING OF (B)(6), AN ECHOCARDIOGRAM WAS PERFORMED. THE PATIENT WAS TRANSFERRED FOR A VENOUS THROMBECTOMY PROCEDURE. PRIOR TO PLACING A GORE 16F SHEATH, THE PHYSICIANS PERFORMED SEVERAL PRE-RUNS AND FOUND THE ILIAC WAS CLEAR WITH NO THROMBUS PRESENT. THROMBUS WAS NOTED FROM THE FEMORAL TO COMMON FEMORAL. THE PATIENT WAS POSITIONED IN A PRONE POSITION FOR A LEFT POPLITEAL ACCESS TO REMOVE A THROMBUS. A 16F SYMPHONY CATHETER WAS POSITIONED THROUGH A GORE 16F SHEATH, AND ASPIRATION STARTED. AFTER THE FIRST PASS IT WAS NOTED THAT CLOT WAS IN THE CATHETER. THERE WAS APPROXIMATELY A 50CC OF BLOOD LOSS. THE ACTIVATED CLOTTING TIME (AC
Patient problems: Pulmonary Embolism
MAUDE report 20741649 ↗
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- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.