Triever24 22-101Recalls & reported problems
Inari Medical, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810123710096), received between Oct 29, 2025 and Jul 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Great Vessel Perforation1
- Pericardial Effusion1
- Stroke/CVA1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Use of Device Problem
One (b)(6) 2026, a patient underwent a thrombectomy procedure using the FlowTriever system of devices. The physician believes the patient developed pericardial effusion due to the size of the catheter.
Patient problems: Pericardial Effusion
MAUDE report 50015352 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, AN 85-YEAR-OLD FEMALE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE FLOWTRIEVER SYSTEM OF DEVICES. THE PROCEDURE ADVANCED THROUGH 4 ASPIRATIONS OF CLOT THIS NO ISSUE. THE PHYSICIAN BEGAN CROSSING TO THE RIGHT WHEN THE PATIENT STARTED SCREAMING. A STROKE TEAM AND ED WAS CALLED AND CONFIRMED STROKE.
Patient problems: Stroke/CVA
MAUDE report 24874087 ↗InjuryOct 29, 2025Use of Device Problem; Use of Device Problem
A (B)(6) YEAR-OLD FEMALE WITH PULMONARY EMBOLISM UNDERWENT A THROMBECTOMY WITH INARI DEVICES. THE PHYSICIAN BEGAN BY WIRING TO THE LEFT SIDE. A BENTSON WIRE WAS USED TO SELECT A VESSEL WHICH ENDED UP BEING A MORE PROXIMAL BRANCH IN THE DISTAL MIDDLE LOBE. THE BENTSON WIRE WAS SWAPPED FOR AN AMPLATZ SUPERSTIFF AND THE TRIEVER24 (T24) WAS ADVANCED. UPON ADVANCING THE T24 THROUGH THE HEART, THE PHYSICIAN FELT THAT THE CATHETER SUDDENLY ADVANCED FORWARD. IMAGING WAS PERFORMED WHICH SHOWED THAT THE T24 HAD ADVANCED VERY DISTAL TO THE END OF THE WIRE. THE T24 WAS BACKED OUT INTO THE ENTRANCE AREA OF THE LEFT PULMONARY ARTERY WHEN THE PATIENT EXPERIENCED HEMOPTYSIS. AN ANGIOGRAM REVEALED A VESSEL PERFORATION IN THE WIRED BRANCH. BALLOONING WAS PERFORMED UNTIL THE BLEEDING HAD STOPPED. THE PERFORATION WAS ALSO EMBOLIZED WITH MULTIPLE COILS. THE PATIENT'S CONDITION IMPROVED ON THE TABLE AND FOLLOW-UP REVEALED THAT THE PATIENT WAS DOING FINE.
Patient problems: Great Vessel Perforation
MAUDE report 23417084 ↗
Other Peripheral Mechanical Thrombectomy With Aspiration devices
- Indigo System LITNG12HTORQ115-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration4 deaths105 reports
- 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 LITNG12HTORQ100-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration1 death46 reports
- Indigo System LITNGBT7TQ130-APenumbra, Inc. · Peripheral Mechanical Thrombectomy With Aspiration46 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.