FlowTriever Catheter, Large 10-103Recalls & reported problems
Inari Medical, Inc. · FlowTriever Catheter, 18 mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00850291007024), received between Jun 26, 2023 and Jun 26, 2023 — classified as 1 injury.
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A 51-YEAR-OLD FEMALE PATIENT UNDERWENT BOWEL SURGERY 2 MONTHS AGO AND AFTER BEING DISCHARGED, THE PATIENT WAS VERY INACTIVE AND DEVELOPED A BILATERAL PULMONARY EMBOLISM (PE). A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE MAIN CLOT BURDEN WAS IN THE RIGHT PULMONARY ARTERY (INTERLOBAR AND TRUNCUS ANTERIOR) WITH A LITTLE ON THE LEFT SIDE. THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE WITH THE INARI FLOWTRIEVER SYSTEM ON (B)(6) 2023. NINE ASPIRATIONS WERE PERFORMED WITH THE INARI TRIEVER24 (T24) WHICH CLEARED THE MAJORITY OF CLOT ON THE RIGHT. THE PHYSICIAN THEN REPOSITIONED THE T24 TO THE MAIN PULMONARY ARTERY AND PERFORMED 3 SUBSEQUENT ASPIRATIONS. AN ANGIOGRAM WAS THEN PERFORMED WHICH SHOWED SOME REMAINING CLOT AND THE PHYSICIAN DECIDED TO USE THE INARI FLOWTRIEVER (FT) L DISKS TO ADDRESS THE REMAINING CLOT. THE DISKS WERE ADVANCED WITHOUT ISSUE AND ONCE THE PHYSICIAN LOCATED THE RADIOPAQUE MARKER BEHIND THE CLOT, THE PHYSICIAN BEGAN RETRACTING THE DELIVERY SYSTEM. HOWEVER, THE DISKS DID NOT OPEN AS EXPECTED AND REMAINED RELATIVELY FLAT. A SECOND ATTEMPT WAS MADE TO INSERT THE DISKS INTO THE DELIVERY SYSTEM, BUT THE RADIOPAQUE MARKER INADVERTENTLY DETACHED FROM THE FT L DISK AND WEN
Patient problems: Foreign Body In Patient
MAUDE report 17206050 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
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- Indigo System LITNG7XTORQ130-APenumbra, Inc. · Peripheral mechanical thrombectomy with aspiration100 reports
- Indigo System LITNG12XTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death80 reports
- ClotTriever XL Catheter AS-0235Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 recall9 deaths20 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 reports
- Indigo System LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Triever 24 22-101Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration20 deaths34 reports
- ClotTriever Catheter, 16 mm 40-102Inari Medical, Inc. · Peripheral Mechanical Thrombectomy With Aspiration11 deaths27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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