FlowTriever Catheter, XL 10-104Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850291007055), received between May 21, 2020 and Nov 7, 2024 — classified as 3 deaths, 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (2 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathNov 7, 2024Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Use of Device Problem

  A 73-YEAR-OLD FEMALE ARRIVED AT THE HOSPITAL 2 WEEKS PRIOR DUE TO DEEP VEIN THROMBOSIS (DVT). THE PATIENT HAS A HISTORY OF DVT, ATRIAL FIBRILLATION, AND HAD A RECENT HYSTERECTOMY. THE HYSTERECTOMY LED TO BLEEDING COMPLICATIONS WHICH RESULTED IN THE PATIENT DISCONTINUING THEIR BLOOD THINNERS. AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL, THEY WERE PLACED ON HEPARIN, THIS LED TO HER BLOOD COUNT DROPPING. THE HEPARIN WAS DISCONTINUED, AND AN INFERIOR VENA CAVA (IVC) FILTER WAS PLACED. THE PATIENT RETURNED TO THE HOSPITAL DUE TO CONTINUED SYMPTOMS. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED MINIMAL PULMONARY EMBOLISM (PE) AND EXTENSIVE CLOT FROM THE LEFT ILIAC INTO THE IVC WHERE THE FILTER WAS PRESENT. THE DECISION WAS MADE TO PERFORM A DVT THROMBECTOMY AFTER REMOVING THE IVC FILTER. THE PATIENT WAS FLIPPED SUPINE, AND ACCESS WAS ACHIEVED. THE IVC FILTER WAS REMOVED THROUGH THE INTERNAL JUGULAR AND THE FLOWTRIEVER CATHETER, XL (FTXL) WITH 2 DISCS DEPLOYED. THE CLOTTRIEVER XL (CTXL) CATHETER WAS USED TO CLEAR THE IVC BUT, THE DISTAL RADIOPAQUE TIP FROM THE FTXL GOT CAUGHT ON THE CTXL. TO ADDRESS THIS, THE FTXL DISCS WERE BRIEFLY DROPPED TO PULL THE CTXL DOWN AND THE PHYSICIAN REDEPLOYED

  Patient problems: Cardiac Arrest; Pulmonary Embolism

  MAUDE report 20635922 ↗
• DeathMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT PRESENTED TO THE HOSPITAL WITH BORDERLINE PHLEGMASIA CERULEA DOLENS IN THE LOWER EXTREMITIES. IMAGING REVEALED THAT THE PATIENT HAD BILATERAL ILIOFEMORAL DEEP VEIN THROMBOSIS (DVT), INFERIOR VENA CAVA (IVC) THROMBUS SUPRARENAL, AND LEFT RENAL VEIN THROMBOSIS. MOST OF THE CLOT WAS ACUTE, WITH SOME SUBACUTE/CHRONIC CLOT THAT WAS WALL ADHERENT IN THE IVC AND LEFT RENAL VEIN. A CHEST COMPUTED TOMOGRAPHY (CT) SCAN ALSO REVEALED A DISTAL LEFT-SIDED CLOT IN THE PULMONARY VEIN, BUT THERE WAS NO RIGHT HEART STRAIN AND NO ELEVATED TROPONIN LEVEL. THE PATIENT WAS NEWLY DIAGNOSED WITH KIDNEY CANCER AND HAD A COVID VIRAL INFECTION 10 DAYS PRIOR. THE CLOT AGE WAS ESTIMATED AT 3 DAYS. THE PATIENT WAS SCHEDULED FOR A THROMBECTOMY ON (B)(6) 2024 USING THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM. THE PROCEDURE WAS CONDUCTED WITH THE PATIENT IN THE SUPINE POSITION. ACCESS WAS OBTAINED VIA THE BILATERAL FEMORAL VEIN; THE CLOTTRIEVER XL CATHETER (CTXL) WAS USED WITH THE CLOTTRIEVER (CT) 16 FR SHEATH AND FLOWTRIEVER XL (FTXL) DISCS CONTRALATERALLY. THE TRIEVER16 (T16) AND TRIEVER16 CURVE (T16 CURVE) WERE ALSO USED TO ASPIRATE ACUTE CLOT IN THE IVC AND LEFT RENAL VEIN WITHOUT INCIDEN

  Patient problems: Discomfort; Pulmonary Embolism; Respiratory Arrest

  MAUDE report 18834141 ↗
• InjuryJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED BY THE COMPANY REPRESENTATIVE WHO WAS PRESENT DURING THE SURGERY AND IT WAS LEARNED THAT EXCESSIVE FORCE WAS BRIEFLY APPLIED WHEN ADVANCING THE FT DISKS. THE SURGEON STOPPED ADVANCING WITHIN SECONDS OF FEELING RESISTANCE, BUT BY THAT TIME THE DISTAL TIP HAD ALREADY DISLODGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THE PATIENT'S STATUS, BUT NO NEW INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17218158 ↗
• DeathMay 21, 2020Use of Device Problem; Use of Device Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH AN INFERIOR VENA CAVA (IVC) FILTER AND A HISTORY OF DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM (PE), AND GASTROINTESTINAL (GI) BLEEDING PRESENTED TO THE HOSPITAL WITH LEG SWELLING. THE PATIENT WAS EXAMINED, PLACED ON ANTICOAGULATION MEDICATION, AND DISCHARGED. THREE DAYS LATER HE RETURNED TO THE HOSPITAL WITH SEVERE LEG PAIN, DISCOLORATION, AND EXTREME SWELLING. WHILE IN THE HOSPITAL, HE TESTED POSITIVE FOR COVID-19. THE PATIENT WAS INELIGIBLE FOR THROMBOLYTIC MEDICAL THERAPY DUE TO THE GI BLEED HISTORY, SO THE PLAN WAS TO TREAT THE BILATERAL DVT SURGICALLY. ON (B)(6) 2020, THE PATIENT UNDERWENT THROMBECTOMY USING THE INARI MEDICAL CLOTTRIEVER SHEATH AND FLOWTRIEVER CATHETER. GENERAL ANESTHESIA WAS ADMINISTERED BECAUSE OF THE COVID-POSITIVE STATUS. WITH THE PATIENT SUPINE, ULTRASOUND WAS USED TO HELP GAIN JUGULAR ACCESS WITH A 5 FR MICROPUNCTURE, WHICH WAS THEN DILATED AND EXCHANGED FOR A 13 FR SHEATH. ULTRASOUND WAS ALSO USED TO HELP GAIN BILATERAL LOWER FEMORAL VEIN ACCESS WITH 5 FR MICROPUNCTURES THAT WERE DILATED AND EXCHANGED FOR 8 FR SHEATHS. VENOGRAMS PERFORMED THROUGH THE 8 FR SHEATHS CONFIRMED SIGNIFICANT CLOT FROM THE IVC FILTER DOW

  Patient problems: Cardiopulmonary Arrest; Pulmonary Embolism; Sudden Cardiac Death

  MAUDE report 10080940 ↗