FlowTriever 2 Catheter, M 11-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850291007192), received between Feb 9, 2023 and Jun 30, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryJun 30, 2023Entrapment of Device; Patient-Device Incompatibility; Detachment of Device or Device Component; Entrapment of Device; Patient-Device Incompatibility; Detachment of Device or Device Component

  A FEMALE PATIENT WITH RECURRENT DEEP VEIN THROMBOSIS (DVT) SYMPTOMS UNDERWENT A THROMBECTOMY PROCEDURE WITH THE INARI TRIEVER20 (T20) AND FLOWTRIEVER2 (FT2) CATHETER IN THE LEFT LEG ON (B)(6) 2023. TWO WEEKS PRIOR TO THIS PROCEDURE, THE PATIENT HAD UNDERGONE A THROMBECTOMY WITH A PENUMBRA SYSTEM AND WAS STENTED WITH AN IVC STENT AFTER THE CASE WAS COMPLETED. THE PATIENT BECAME SYMPTOMATIC AGAIN ONE DAY PRIOR TO UNDERGOING THE INARI THROMBECTOMY PROCEDURE. ACCESS WAS ACHIEVED IN THE LEFT FEMORAL VEIN AND CLOT WAS ASPIRATED USING THE TRIEVER20. THERE WAS AN ANEURYSMAL SECTION OF THE STENT ON THE MEDIAL SIDE OF THE ILIAC VEIN WITH CLOT PRESENT; AN FT2 CATHETER WAS USED TO ADDRESS THIS CLOT. TWO PASSES WERE PERFORMED SUCCESSFULLY WITH THE FT2 WITH ASPIRATIONS FROM THE T20. AFTER SEVERAL IVUS WITH CONTRAST RUNS WERE PERFORMED, THE SURGEON DECIDED TO ATTEMPT A THIRD PASS. DURING THIS ATTEMPT, THE FT2 EXPANDABLE (MESH) ELEMENT BECAME STUCK IN THE SAME SEGMENT WHERE THE CLOT WAS PRESENT. ANOTHER SURGEON WAS CALLED IN AND AFTER CONSULTATION, THE SURGEON SEVERED THE IMPLANTED STENT IN HALF AND USED AN ENDURANT II MEDTRONIC STENT TO COVER THE DISSECTED STENT AND THE SEGMENT WITH THE SMALL FT2

  Patient problems: Foreign Body In Patient

  MAUDE report 17242856 ↗
• MalfunctionFeb 9, 2023Peeled/Delaminated; Stretched; Material Split, Cut or Torn; Peeled/Delaminated; Stretched; Material Split, Cut or Torn

  ON (B)(6) 2023, A THROMBECTOMY WAS SCHEDULED FOR AN 80-YEAR-OLD FEMALE WITH A PULMONARY EMBOLISM. A FLOWTRIEVER 2 (FT2) CATHETER WAS OPENED FOR THE PROCEDURE. UPON INSPECTION, THE USER REPORTED OBSERVING THAT THE DEVICE HAD PLASTIC WHICH WAS SHEARED OFF THE CATHETER. THE FT2 WAS NEVER PLACED IN THE PATIENT. ANOTHER FT2 CATHETER WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ON JANUARY 23, 2023, THE FDA INFORMED INARI MEDICAL OF A VOLUNTARY MEDWATCH REPORT (#MW5114311) THAT HAD BEEN FILED. THE EVENT DESCRIBED IN THIS VOLUNTARY REPORT WAS CONFIRMED TO BE THE SAME DEVICE PROBLEM DESCRIBED ABOVE. THE USER REPORTED THE FOLLOWING PROBLEM: "INARI FLOWTRIEVER 2. THE INNER PLASTIC OF THE FLOWTRIEVER 2 DEVICE BROKE OFF AND CAN EMBOLIZE INTO THE PATIENT. THIS WAS LUCKILY CAUGHT BEFORE WE PLACED IT INTO THE PATIENT. HOWEVER, THE DEVICE BROKE BEFORE IT WAS EVEN USED. THIS IS VERY DANGEROUS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16343163 ↗