Artix MT 32-102 / AS-01248Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810123710584), received between May 20, 2025 and Nov 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 8, 2025Class IIOpen, Classified

   Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

   Z-1728-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Entrapment of Device; Entrapment of Device

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING STENT IN HIS POSTERIOR TIBIAL ARTERY. DURING THE THROMBECTOMY, THE ARTIX MT THROMBECTOMY DEVICE (MT6) CAUGHT ON THE PATIENT'S PREEXISTING STENT AT AN AREA OF OVERLAP. THE PHYSICIAN ATTEMPTED TO RESHEATH THE MT6 AND PUSH THE DEVICE FORWARD; HOWEVER, THE DEVICE WAS ONLY ABLE TO PARTIALLY RESHEATH AND WAS UNABLE TO MOVE FORWARD. THE PHYSICIAN THEN ATTEMPTED TO OVERSHEATH THE DEVICE WITH A LARGER SHEATH BUT WAS ALSO UNSUCCESSFUL. THE MT6 WAS EVENTUALLY REMOVED, HOWEVER THE PATIENT'S PREEXISTING STENT WAS FRACTURED. AS A RESULT OF THE FRACTURED STENT, THE MEDICAL TEAM CONSIDERED A BELOW THE KNEE AMPUTATION AS A POTENTIAL NEXT STEP. WHETHER AN AMPUTATION WAS CARRIED OUT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23623744 ↗
• InjuryOct 29, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) , 2025, AN (B)(6) -YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A STENT IMPLANTED IN HIS RIGHT POPLITEAL ARTERY TWO WEEKS PRIOR TO THE THROMBECTOMY. DURING THE PROCEDURE, THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) BECAME CAUGHT ON THE DISTAL PART OF THE STENT WHEN PULLING THE MT6 THROUGH THE STENT. THE PHYSICIAN TRIED TO BACK THE DEVICE OUT; HOWEVER, IT WOULD NOT RETRACT. THE PATIENT WAS TRANSFERRED TO THE CARDIOVASCULAR OPERATING ROOM, AND THE SURGEON ACCESSED THE POPLITEAL ARTERY BELOW THE STENT. THE STENT AND THE ARTIX MT6, WHICH SEPARATED AT THE DISTAL END, WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH AND OUT OF THE PATIENT'S LEG.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23418579 ↗
• InjuryJul 29, 2025Migration; Migration

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED TO BE 17 DAYS OLD. THE PATIENT HAD A PREEXISTING STENT (LESS THAN ONE YEAR OLD) IN HIS RIGHT SUPERFICIAL FEMORAL ARTERY. DURING THE THROMBECTOMY, THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) BECAME CAUGHT IN THE PROXIMAL PORTION OF THE PATIENT'S PREEXISTING STENT, WHICH RESULTED IN THE STENT BREAKING AND GETTING STUCK ON THE MT6. THE ENTIRE STENT MIGRATED PROXIMAL TO THE ARTERY. THE MT6 AND ARTIX COVERED FUNNEL CATHETER WERE REMOVED TOGETHER. THE PATIENT'S ARTERY WAS RELINED WITH A NEW STENT AND THE PROCEDURE WAS TERMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652167 ↗
• InjuryMay 20, 2025Migration; Migration

  ON (B)(6) 2025, A 62-YEAR-OLD MALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PREEXISTING STENTS IN THE RIGHT SUPERFICIAL FEMORAL AND RIGHT POPLITEAL ARTERIES. DURING THE THROMBECTOMY, THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) WAS ADVANCED INSIDE A LONG SEGMENT STENT AND CLOT WAS REMOVED. THE NEXT PASS, THE MT6 WAS ADVANCED MORE DISTAL THROUGH THE LONG STENTED SEGMENT AND WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE MT6 BECAME STUCK ON ONE OF THE PRE-EXISTING STENTS. THE DOCTOR RESHEATHED THE MT6 INSIDE THE STENT AND WHEN THE DEVICE WAS REMOVED, IT WAS NOTED TWO PIECES OF THE STENT WERE REMOVED AS WELL. THE MEDICAL TEAM USED AN ARTIX AX ASPIRATION CATHETER TO COMPLETE THE CASE. STENTING WAS DONE AFTER THE THROMBECTOMY, AND FULL FLOW WAS RESTORED POST THROMBECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057382 ↗