InThrill Thrombectomy Catheter 43-102Recalls & reported problems
Inari Medical, Inc. · InThrill Thrombectomy Catheter (AS-01312) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810123710126), received between Sep 3, 2025 and May 14, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Use of Device Problem
ON, (B)(6) 2026, A PATIENT UNDERWENT AN AV GRAFT DECLOT PROCEDURE USING THE IN THRILL DEVICE. DURING THE PROCEDURE, THE DEVICE WAS INTERFERED WITH AND DEFORMED BY AN EXISTING STENT. THE DR WAS ABLE TO APPLY ANOTHER STENT, COMPLETE THE PROCEDURE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS OR INJURY AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175047 ↗MalfunctionSep 3, 2025Break; Break
ON (B)(6) 2025, A 60-YEAR OLD FEMALE UNDERWENT DEEP VEIN THROMBOSIS (DVT) THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 45 DAYS. THE PATIENT HAD A HISTORY OF CANCER AND HAD A PORT IN THE SUPERIOR VENA CAVA (SVC). UPON ARRIVAL AT THE HOSPITAL, THE PATIENT HAD A COMPLETE OBSTRUCTION IN THEIR CATHETER PORT AND NO FLOW TO THE SVC. DURING THE THROMBECTOMY, CLOT WAS REMOVED WITH THE FIRST PASS OF THE ENTHRALL THROMBECTOMY CATHETER (ENTHRALL). THE MEDICAL TEAM WAS UNABLE TO REMOVE ALL THE CLOT FROM THE INTRHILL CORING ELEMENT USING THE INCLUDED ELEMENT SUPPORT TOOL AND WIPES, THUS THE MEDICAL TEAM USED FORCEPS TO REMOVE THE LAST PIECES OF CLOT THAT WERE ADHERING TO THE CORING ELEMENT. THE MEDICAL TEAM THEN NOTICED A NITINOL ELEMENT STRUT ON THE INTHRILL CORING ELEMENT APPEARED TO BE SEVERED FROM THE REST OF THE BASKET AND WAS STICKING OUT. THE MEDICAL TEAM ATTEMPTED TO RESHEATH THE DEVICE, HOWEVER THE WIRE COULD NOT BE RESHEATHED INTO THE CATHETER. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22958180 ↗
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 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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