Triever 20 Curve 21-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850291007215), received between Dec 4, 2023 and Sep 12, 2024 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjurySep 12, 2024Use of Device Problem; Use of Device Problem

  AN 81-YEAR-OLD FEMALE UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM TO ADDRESS HER PULMONARY EMBOLISM. A STIFF ANGLED GLIDEWIRE WAS USED IN CONJUNCTION WITH A VERT CATHETER TO WIRE THE TRUNCUS ANTERIOR. THE WIRE APPEARED TO ADVANCE IN THE APPROPRIATE DIRECTION WITHIN THE VESSEL. THE GLIDEWIRE WAS EXCHANGED FOR AN AMPLATZ SUPERSTIFF GUIDEWIRE. THE TRIEVER20 CURVE WAS INTRODUCED COAXIAL WITH THE TRIEVER24 TO THE RIGHT PULMONARY ARTERY (RPA) AND AN ASPIRATION WAS PERFORMED. THE PHYSICIAN PERFORMED A SELECTIVE ANGIOGRAM OF THE RPA WHEN IT WAS NOTICED THAT THE IMAGE LOOKED ODD. THE CATHETERS WERE PULLED BACK, AND ANOTHER ANGIOGRAM WAS PERFORMED WHICH REVEALED EXTRAVASATION OF CONTRAST AND A LARGE PERICARDIAL EFFUSION. THE PROCEDURE WAS HALTED, AND THE PATIENT DECOMPENSATED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED THE PERICARDIAL EFFUSION. A PERICARDIAL DRAIN WAS INSERTED BUT THE PATIENT CONTINUED TO DECOMPENSATE. THE PATIENT WAS INTUBATED, AND A TRANSESOPHAGEAL ECHOCARDIOGRAM PROBE WAS PLACED. MULTIPLE ATTEMPTS WERE MADE TO ALLOW THE BLEEDING TO STOP ON ITS OWN. AT ONE POINT THE SURGICAL TEAM PREPPED THE PATIENT AND THE PATIENT'S CHEST WAS OPENED FOR REPAIR. THE PAT

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Cardiogenic Shock

  MAUDE report 20207802 ↗
• DeathDec 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A 78-YEAR-OLD FEMALE WITH LEFT LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) UNDERWENT A THROMBECTOMY WITH THE INARI CLOTTRIEVER SYSTEM. THE CLOT AGE WAS ESTIMATED AT 5 DAYS. THE PROCEDURE WAS PERFORMED UNDER MONITORED ANESTHESIA WITH THE PATIENT IN A PRONE POSITION. WIRE POSITIONING WAS SUCCESSFULLY OBTAINED AND THE CLOTTRIEVER BOLD CATHETER WAS ADVANCED. TWO PASSES WERE PERFORMED BEFORE THE HEART RATE DECREASED FROM A BASELINE OF 75 BPM TO THE 60 RANGE. THE PATIENT CONTINUED TO DETERIORATE AS IMAGING WAS ATTEMPTED. A VENOGRAM OF THE LOWER LEFT EXTREMITY REVEALED NO CLOT BURDEN INDICATING A POTENTIAL EMBOLISM. THE HEART RATE FURTHER DECLINED (50 BPM RANGE) AND THE PATIENT WAS REPOSITIONED SUPINE. CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. THE PULMONARY ANGIOGRAM CONFIRMED A PULMONARY EMBOLISM ON THE LEFT SIDE AND THE SURGEON CONVERTED TO USE OF THE FLOWTRIEVER. WIRE POSITIONING WAS OBTAINED AND A TRIEVER24 (T24) WAS INSERTED BUT WOULD NOT ADVANCE PAST THE CURVATURE OF THE LEFT PULMONARY ARTERY; A TRIEVER20 CURVE (T20C) WAS THEN TELESCOPED THROUGH THE T24. AN ASPIRATION WAS PERFORMED WHICH RESULTED IN AN OBSTRUCTION. THE DEVICE WAS REMOVED FROM

  Patient problems: Arrhythmia; Cardiac Arrest; Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18400529 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN 88-YEAR-OLD FEMALE PATIENT PRESENTED TO THE HOSPITAL WITH MILD RIGHT HEART STRAIN. COMPUTED TOMOGRAPHIC ANGIOGRAPHY (CTA) CONFIRMED THE PRESENCE OF CLOT IN THE RIGHT INTERLOBAR AND TRUNCUS AS WELL AS SMALL CLOT ON THE LEFT INTERLOBAR. THE PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM (PE). ADDITIONALLY, THE PATIENT HAD A "DO NOT RESUSCITATE" (DNR) ORDER AND HAD BEEN IN A MOTOR VEHICLE ACCIDENT ONE MONTH PRIOR WHERE SHE SUSTAINED HIP FRACTURES. THE CLOT AGE WAS ESTIMATED AT 10 DAYS. A THROMBECTOMY WAS PERFORMED WITH THE INARI FLOWTRIEVER SYSTEM. WIRE POSITIONING WAS OBTAINED AND THE TRIEVER24 (T24) WAS ADVANCED. A SINGLE ASPIRATION WAS PERFORMED WHICH YIELDED CLOT. THE PHYSICIAN THEN REPOSITIONED INTO THE TRUNCUS IN WHICH ANOTHER ASPIRATION WAS PERFORMED. THE PHYSICIAN THEN PULLED THE T24 INTO THE MAIN PULMONARY ARTERY WHEN IT WAS NOTED THAT THE GUIDEWIRE APPEARED TO BE IN THE LEFT INTERLOBAR AREA AND ADVANCED SLIGHTLY. THE WIRE WAS NOT DISTAL BUT WAS FACING INFERIOR. THE PHYSICIAN OPENED A TRIEVER20 CURVE (T20C) CATHETER AND ADVANCED IT OVER THE GUIDEWIRE. WHILE ADVANCING THE T20C CATHETER, THE PATIENT COMPLAINED OF CHEST PAIN DESPITE EXHIBITING STABLE VITAL SIGNS. THE PHYSICIAN

  Patient problems: Cardiac Arrest; Cardiac Perforation; Chest Pain; Hemoptysis; Intraoperative Pain; Ventricular Fibrillation

  MAUDE report 18263822 ↗