ClotTriever Sheath, 13 Fr AS-01261/ 50-101Recalls & reported problems

Inari Medical, Inc. · ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System) · Class 2

All models of ClotTriever Sheath, 13 Fr (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810123710058), received between Mar 3, 2026 and Mar 20, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Entrapment of Device2
Detachment of Device or Device Component1
Material Separation1

Patient problems

Vascular Dissection2
Foreign Body Embolism1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjuryMar 20, 2026Entrapment of Device; Detachment of Device or Device Component
ON (B)(6) 2026 A PATIENT UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING STRYKER PERIPHERAL VASCULAR DEVICES. A TOTAL OF SIX PASSES WERE PERFORMED USING THE CLOTTRIEVER CATHETER (CT CATHETER) THROUGH THE CLOTTRIEVER SHEATH, 13FR (CT SHEATH). FOLLOWING THE SIXTH PASS, THE CT CATHETER WAS REMOVED AND WHILE REMOVING THE CT SHEATH, IT WAS NOTICED THAT THE FUNNEL WAS SEPARATED FROM THE SHEATH AND REMAINED SUBCUTANEOUS. THE FUNNEL WAS SURGICALLY REMOVED.
Patient problems: Vascular Dissection
MAUDE report 24653547 ↗
InjuryMar 3, 2026Entrapment of Device; Material Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE CLOTTRIEVER SYSTEM OF DEVICES. ACCESS VIA GUIDEWIRE WAS ESTABLISHED. THE CLOTTRIEVER SHEATH WAS INSERTED. THE PROCEDURE WAS GOING SMOOTHLY UNTIL THE PATIENT FELT PAIN. X-RAY WAS UTILIZED TO OBTAIN VISUALIZATION AND A CLINICAL SUPPORT STAFF MEMBER NOTICED THE END OF THE SHEATH¿S FUNNEL WAS SLIGHTLY CURVED. THE PATIENT WAS SUPINE, IN A FROG-LEG POSITION. THE DOCTOR DECIDED TO REMOVE THE CLOTTRIEVER SHEATH TO CHECK IT. THERE WAS NOT MUCH RESISTANCE FELT BY THE SURGEON WHEN REMOVING THE SHEATH, BUT UPON INSPECTION, THE FUNNEL WAS MISSING. THE DOCTORS PERFORMED A VENOUS CUTDOWN TO REMOVE THE FUNNEL AND THEN CLOSED THE RIGHT POPLITEAL ACCESS.
Patient problems: Foreign Body Embolism; Vascular Dissection
MAUDE report 24501599 ↗

Device details

UDI-DI	`00810123710058`
Brand	ClotTriever Sheath, 13 Fr
Model	AS-01261/ 50-101
Catalog no.	50-101
Company	Inari Medical, Inc.
Product code	QEW · Peripheral Mechanical Thrombectomy With Aspiration
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 9, 2026

Device type (GMDN): Thrombectomy wire-net introduction set

A dedicated collection of manual invasive devices intended to provide percutaneous vascular access to enable the introduction, and safe retrieval, of a thrombectomy wire-net (not included) during a thrombectomy procedure. It includes a non-steerable sheath typically with an expanding distal funnel to facilitate wire-net retrieval, an obturator/dilator, a haemostatic valve to control blood loss, and a side port. It is typically also designed to allow removal of residual clotted blood, trapped in the sheath funnel upon retrieval, through manual suction (aspiration). This is a single-use device.

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All Peripheral Mechanical Thrombectomy With Aspiration devices →

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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