Triever 16 25-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850291007130), received between Sep 5, 2020 and May 28, 2026 — classified as 4 deaths, 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. THE DISTAL PORTION OF THE CATHETER SEPARATED AND REQUIRED ADDITIONAL DEVICES TO REMOVE IT INTRAVASCULARLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 25319084 ↗
• MalfunctionJun 10, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 42-YEAR-OLD MALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) THROMBECTOMY USING INARI DEVICES. WHILE THE TRIEVER16 (T16) WAS BEING PREPARED FOR ANOTHER PASS, THE TECHNICIAN ADJUSTED A BEND IN THE T16 CATHETER, AND THE CATHETER SUBSEQUENTLY SEPARATED. A NEW DEVICE WAS OPENED, AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178365 ↗
• MalfunctionJun 10, 2025Retraction Problem; Material Separation; Retraction Problem; Material Separation

  ON (B)(6) 2025, A 35-YEAR-OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. UPON REMOVAL OF THE TRIEVER16 (T16), DURING THE THROMBECTOMY, SOME RESISTANCE WAS FELT. THE T16 BROKE IN HALF WITH THE TWO HALVES CONNECTED BY THE INNER COIL. THE DEVICE WAS ABLE TO BE FULLY REMOVED FROM THE PATIENT WITHOUT ISSUE AND THERE WAS NO INJURY TO THE PATIENT. A NEW DEVICE WAS OPENED AND THE THROMBECTOMY WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22177174 ↗
• MalfunctionAug 28, 2024Retraction Problem; Material Separation; Retraction Problem; Material Separation

  ON (B)(6) 2024, A 57-YEAR-OLD MALE WITH DEEP VEIN THROMBOSIS (DVT) UNDERWENT DVT THROMBECTOMY USING INARI DEVICES. THE CLOT AGE ESTIMATE WAS 21 DAYS OLD. DURING THROMBECTOMY, THE PATIENT'S RIGHT POPLITEAL VEIN WAS USED AS THE PRIMARY ACCESS SITE. WHILE REMOVING THE TRIEVER16 THROUGH THE POPLITEAL, THE CATHETER BROKE, LEAVING PART OF THE CATHETER IN THE PATIENT'S VEIN WHILE THE PROXIMAL PART OF THE CATHETER WAS REMOVED. THE PHYSICIAN WAS ABLE TO FULLY REMOVE THE SEPARATED PORTION OF THE CATHETER FROM THE PATIENT BY SLOWLY PULLING THE SEPARATED PART FROM THE PATIENT'S BODY THROUGH THE ACCESS SITE. THE PHYSICIAN CONFIRMED THERE WAS NO INJURY TO THE PATIENT'S VESSEL THROUGH FLUOROSCOPY. THE CASE WAS COMPLETED, AND NO FURTHER INTERVENTION WAS REQUIRED. IT WAS ESTIMATED THAT 80% OF THE CLOT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20087094 ↗
• InjuryFeb 15, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  A 78-YEAR-OLD MALE PATIENT WITH BILATERAL LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) WITH SOME CLOT PRESENT IN THE INFERIOR VENA CAVA (IVC) UNDERWENT A THROMBECTOMY USING THE INARI FLOWTRIEVER SYSTEM ON (B)(6) 2024. THE CLOT AGE WAS ESTIMATED AT 5 DAYS. AFTER ACCESS WAS OBTAINED AND A CLOTTRIEVER 16 FR SHEATH WAS PLACED, THE TRIEVER16 (T16) WAS ADVANCED THROUGH THE CT SHEATH INTO THE INFERIOR VENA CAVA. THE PHYSICIAN REPORTED FEELING RESISTANCE SUPERIOR TO THE RENAL VEINS. AN ASPIRATION WAS PERFORMED BUT NO CLOT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE T16 BACK TOWARDS THE SHEATH BUT ENCOUNTERED RESISTANCE A SECOND TIME. THE PHYSICIAN CONTINUED APPLYING PULLING FORCE TO THE POINT OF DEVICE SEPARATION/BREAKAGE AND THE T16 UNRAVELED INSIDE THE VESSEL. THERE WAS NO RESULTING VESSEL PERFORATION. INTERVENTION WAS PERFORMED TO RETRIEVE THE DEVICE FRAGMENT FROM THE PATIENT (USING A 10 MM FOGARTY BALLOON OVER THE GUIDEWIRE). THE FRAGMENTS WERE COMPLETELY REMOVED FROM THE ORIGINAL INCISION SITE AND THE CLOTTRIEVER 16 FR SHEATH WAS REMOVED WITHOUT INCIDENT. A CLOTTRIEVER 13FR SHEATH WAS THEN INSERTED AND THE THROMBECTOMY WAS COMPLETED SUCCESSFULLY USING THE CLOTTRIEVER SYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718196 ↗
• DeathSep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD FEMALE UNDERWENT ATTEMPTED THROMBECTOMY WITH THE INARI FLOWTRIEVER SYSTEM DUE TO PREEXISTING BILATERAL PULMONARY EMBOLISM (PE). THE PATIENT HAD A HIP FRACTURE AND SURGERY ONE MONTH PRIOR TO THE THROMBECTOMY AND PRESENTED AS AN INTERMEDIATE-HIGH RISK PATIENT. DURING AN ASPIRATION WITH THE TRIEVER16, THE PATIENT EXPERIENCED AN ACUTE ONSET OF CHEST PAIN AND MASSIVE HEMOPTYSIS. THE PATIENT RAPIDLY PROGRESSED TO ASYSTOLIC CARDIAC ARREST. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED PERFORATION OF THE DISTAL SEGMENT OF THE LEFT MAIN PULMONARY ARTERY. OCCLUSION OF THE PROXIMAL ARTERY WAS PERFORMED WITH A BALLOON AND SELECTIVE INTUBATION WAS PERFORMED TO EXCLUDE THE LEFT PULMONARY ARTERY AND MAIN BRONCHUS. ADVANCED CARDIAC LIFE SUPPORT WAS PERFORMED FOR 40 MINUTES, BUT EFFORTS WERE NOT SUCCESSFUL IN OBTAINING SPONTANEOUS CIRCULATION AND UNFORTUNATELY THE PATIENT EXPIRED.

  Patient problems: Asystole; Cardiac Arrest; Cardiac Perforation; Chest Pain; Great Vessel Perforation; Hemoptysis; Intraoperative Pain

  MAUDE report 17750495 ↗
• InjuryJul 27, 2023Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  A 58-YEAR-OLD FEMALE PATIENT WITH A COMPLEX MEDICAL HISTORY (DESCRIBED IN B7) HAD BEEN EXPERIENCING SHORTNESS OF BREATH FOR 2 WEEKS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED PULMONARY EMBOLISM (PE) AND THE CLOT AGE WAS ESTIMATED AT 2 WEEKS. A THROMBECTOMY WAS PERFORMED WITH THE INARI FLOWTRIEVER SYSTEM TO ADDRESS THE PE. AFTER WIRE POSITIONING WAS OBTAINED, TWO ASPIRATIONS WERE PERFORMED WITH THE TRIEVER24 (T24) CATHETER WHICH YIELDED VERY CHRONIC AND SUBSTANTIAL CLOT. THE PHYSICIAN THEN ATTEMPTED TO RE-WIRE TO THE LEFT SIDE WITH THE AMPLATZ GUIDEWIRE, BUT NEEDED TO USE A J WIRE AND PENUMBRA 5F 130 CATHETER. WHEN THE T24 WAS UNABLE TO ADVANCE PAST THE MAIN PULMONARY ARTERY, THE TRIEVER16 (T16) CURVE WAS USED THROUGH THE T24. THE T16 WAS POINTED DOWN AT THE SUPER SEGMENT BRANCH LEVEL AND THERE WAS NO WIRE VISUALIZATION THROUGH THE T16 CATHETER. THE GUIDEWIRE WAS PULLED BACK AND THE AMPLATZ GUIDEWIRE WAS ADVANCED. HOWEVER, THE T16 CURVE WAS CURVED IN AN UNEXPECTED MANNER AND THE PHYSICIAN SUSPECTED THAT THE T16 MAY HAVE BEEN POSITIONED IN THE HEART. THE T24 AND T16 CATHETERS WERE PULLED BACK (TOGETHER) INTO THE MAIN PULMONARY ARTERY. IMAGING WAS PERFORMED IN WHICH CONTRAST DID NO

  Patient problems: Cardiac Arrest; Cardiac Perforation; Cardiac Tamponade

  MAUDE report 17408469 ↗
• MalfunctionOct 13, 2022Break; Collapse; Entrapment of Device; Material Separation; Break; Collapse; Entrapment of Device; Material Separation

  A FEMALE PATIENT IN HER EARLY 40S WAS DIAGNOSED WITH A CHRONIC DEEP VEIN THROMBOSIS (DVT) IN THE LEFT LEG. ON (B)(6) 2022, THE PATIENT UNDERWENT A THROMBECTOMY WITH THE INARI FLOWTRIEVER RETRIEVAL/ASPIRATION SYSTEM. WHILE UTILIZING THE TRIEVER16 (T16) IN THE LEFT POPLITEAL VEIN, A PORTION OF THE T16 BROKE OFF INTO THE DEEP FEMORAL VEIN. AT THIS POINT, APPROXIMATELY 10% OF THE CLOT HAD BEEN RETRIEVED. THE PHYSICIAN WAS ABLE TO ADVANCE A KELLY FORCEPS A FEW CENTIMETERS INTO THE ACCESS TRACK AND SUCCESSFULLY REMOVE THE BROKEN PIECE. THERE WAS NO RESULTING PATIENT HARM. THE TREATING PHYSICIAN SUSPECTED THE PATIENT HAD SCAR TISSUE THAT CAUGHT ON THE T16 CATHETER. THE COMPANY REPRESENTATIVE PRESENT DURING THE CASE CLARIFIED THAT THE PROCEDURE WAS COMPLETED UNEVENTFULLY USING BALLOON DILATION TO ADDRESS THE SCAR TISSUE IN THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15602183 ↗
• InjuryFeb 17, 2021Improper or Incorrect Procedure or Method

  A (B)(6)-YEAR-OLD FEMALE PATIENT WITH CHRONIC PANCREATITIS PRESENTED TO THE EMERGENCY DEPARTMENT WITH HYPERTENSION AND SUSPECTED ACUTE MYOCARDIAL INFARCTION (MI). SHE WAS DIAGNOSED WITH A PULMONARY EMBOLISM (PE) AFTER UNDERGOING A RIGHT HEART CATHETERIZATION AND PULMONARY ANGIOGRAM (ACUTE MI WAS RULED OUT). ON (B)(6) 2021, THE INARI TRIEVER16 (T16), TRIEVER20 (T20), AND MEDIUM FLOWTRIEVER (FT) DISKS WERE USED TO ATTEMPT TO TREAT THE PE. THE PATIENT REMAINED HYPERTENSIVE AND TACHYCARDIC THROUGHOUT THE MECHANICAL THROMBECTOMY, WITH MARKEDLY ELEVATED RIGHT-SIDED PULMONARY AND ATRIAL PRESSURES. THE CLOT IN THE RIGHT PULMONARY ARTERY WAS SUCCESSFULLY ASPIRATED, BUT CLOT REMAINED IN THE LEFT LOWER LOBE (LLL) DESPITE USE OF THE T20, T16, AND MEDIUM FT DISKS. AN EKOS CATHETER WAS PLACED DUE TO THE PERSISTENT TACHYCARDIA, AND THE CASE WAS CONCLUDED. THE FOLLOWING DAY, RIGHT HEART CATHETERIZATION REVEALED RESOLUTION OF RIGHT VENTRICLE FAILURE AND NORMALIZATION OF RIGHT ATRIAL PRESSURE (~20 REDUCED TO ~6 MMHG). THE PATIENT'S TACHYCARDIA AND NAUSEA PERSISTED, AND THE HGB LEVEL DECREASED FROM 9 TO 7 GM/DL DUE TO 600 CC OF BLOOD BEING ASPIRATED DURING THE PROCEDURE. THE PATIENT WAS INFUSED WITH

  Patient problems: Anemia; Hematoma; High Blood Pressure/ Hypertension; Hypovolemia

  MAUDE report 11336325 ↗
• DeathJan 21, 2021Use of Device Problem; Use of Device Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN ON (B)(6) 2020. SHE WAS ADMITTED TO THE CATHETERIZATION LAB, WHERE SHE UNDERWENT PERCUTANEOUS CORONARY INTERVENTION AND RECEIVED 2 CORONARY STENTS. ON (B)(6) 2020, AS THE PATIENT WAS RECOVERING FROM THE PROCEDURE, SHE BEGAN EXPERIENCING CHEST PAIN WITH SHORTNESS OF BREATH. A CT ANGIOGRAM REVEALED A SADDLE PULMONARY EMBOLISM (PE) WITH BILATERAL CLOT BURDEN. ON (B)(6) 2020, THE INARI MEDICAL TRIEVER20 (T20), TRIEVER16 (T16), AND MEDIUM FLOWTRIEVER (FT) DISKS WERE USED TO ATTEMPT TO TREAT THE PE. PRIOR TO THE CASE, IT WAS NOTED THAT THE PATIENT HAD SOME RIGHT VENTRICLE STRAIN, ELEVATED TROPONIN LEVELS, AND A HEMOGLOBIN LEVEL OF OVER 12 G/DL. AS THE CASE BEGAN, THE PATIENT'S HEART RATE WAS BETWEEN 130-150 BPM, AND BLOOD PRESSURE WAS 152/72 MMHG. ACCESS WAS GAINED VIA THE RIGHT COMMON FEMORAL VEIN, AND A BENTSON WIRE AND ANGLED PIGTAIL CATHETER WERE USED TO SUCCESSFULLY CROSS THE HEART AND ADVANCE TO THE MAIN PULMONARY ARTERY (PA); THE PA PRESSURE WAS 54/30/14 MMHG. THE WIRE WAS THEN MANEUVERED TO THE RIGHT PA AND EXCHANGED FOR A BOSTON SCIENTIFIC AMPLATZ SUP

  Patient problems: Cardiac Arrest; Hypovolemic Shock; Hypoxia; Loss of consciousness; Low Blood Pressure/ Hypotension; Oversedation; Respiratory Arrest

  MAUDE report 11211512 ↗
• DeathJan 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING ADDITIONAL EVENT INFORMATION WAS PROVIDED TO INARI ON (B)(6) 2021. THE DAY BEFORE THE PROCEDURE, THE TEE DID NOT REVEAL ANY EVIDENCE OF A PERICARDIAL EFFUSION. ON THE DAY OF THE PROCEDURE, THE PATIENT WAS INTUBATED AND A SECOND TEE WAS PERFORMED, WHICH IDENTIFIED SOME SMALL PERICARDIAL EFFUSION; HOWEVER, THERE WAS NO SURGICAL PLAN TO TREAT AS IT WAS NOT BELIEVED TO BE SEVERE. AFTER THE CASE CONCLUDED AND THE COMPANY REPRESENTATIVE LEFT THE FACILITY, THE PATIENT EXPERIENCED WHAT WAS BELIEVED TO BE A REPERFUSION INJURY AND WAS STABILIZED ON A VENTILATOR. A BRONCHOSCOPY CONFIRMED NO SIGNS OF BLEEDING. THE PATIENT SUBSEQUENTLY DETERIORATED AND THE CAUSE OF DEATH WAS LISTED AS ACUTE SEVERE HYPOXIC RESPIRATORY FAILURE, ACUTE RIGHT VENTRICLE HEART FAILURE, AND CARDIOPULMONARY ARREST.

  Patient problems: Hemoptysis; Hypovolemia; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pericardial Effusion

  MAUDE report 11182618 ↗
• DeathSep 5, 2020Use of Device Problem; Use of Device Problem

  A (B)(6)-YEAR-OLD FEMALE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH ON (B)(6) 2020. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL, WHERE A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A PULMONARY EMBOLISM (PE). THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, WHERE SHE WAS PLACED ON SYSTEMIC HEPARIN. THE PATIENT DID NOT IMPROVE BY THE EARLY EVENING OF (B)(6) 2020; THEREFORE THE INTERVENTIONAL RADIOLOGIST SCHEDULED A THROMBECTOMY USING THE INARI MEDICAL TRIEVER24 (T24) TO ADDRESS THE PE. PRIOR TO THE CASE, THE PATIENT'S VITAL SIGNS WERE: RV/LV RATIO 2.14, HEART RATE 102 BPM, BLOOD PRESSURE 140/93, OXYGEN SATURATION 95% ON 50 L/MIN, AND 13.6 G/DL HEMOGLOBIN. THE PATIENT HAD EATEN EARLIER IN THE DAY SO THE ANESTHESIOLOGIST INTUBATED THE PATIENT AND ADMINISTERED GENERAL ANESTHESIA. USING ULTRASOUND AND A MICROPUNCTURE KIT, THE PHYSICIAN GAINED ACCESS VIA THE RIGHT FEMORAL VEIN. AN EXCHANGE CATHETER WAS PLACED OVER THE WIRE, THEN A BOSTON SCIENTIFIC AMPLATZ SUPER STIFF GUIDEWIRE WAS INSERTED THROUGH THE EXCHANGE CATHETER AND INTO THE INFERIOR VENA CAVA. THE MICROPUNCTURE SHEATH WAS THEN EXCHANGED FOR A 24F GORE DRYSEAL SHEATH AND 7000 UNITS OF HEPARIN WERE ADMINISTER

  Patient problems: Cardiogenic Shock; Cardiopulmonary Arrest; Death; Great Vessel Perforation; Hemoptysis

  MAUDE report 10498024 ↗