FlowTriever Catheter, M 10-102Recalls & reported problems
Inari Medical, Inc. · FlowTriever Catheter, 14 mm · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850291007017), received between Feb 17, 2021 and Feb 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Anemia1
- Hematoma1
- High Blood Pressure/ Hypertension1
- Hypovolemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2021Improper or Incorrect Procedure or Method
A (B)(6) 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 2 UNITS O
Patient problems: Anemia; Hematoma; High Blood Pressure/ Hypertension; Hypovolemia
MAUDE report 11336350 ↗
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- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.