Artix MT 32-103 / AS-01244Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00810123710591), received between Apr 2, 2025 and May 26, 2026 — classified as 6 injuries, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Material Separation

  ON (B)(6) 2026, A FEMALE PATIENT UNDERWENT LOWER LEFT EXTREMITY THROMBECTOMY USING STRYKER DEVICES. THE PROCEDURE WAS SUCCESSFUL. AFTER COMPLETION OF THE PROCEDURE, FLUOROSCOPY SHOWED PRESENCE OF A RADIOPAQUE MARKER BAND FROM THE ATRIX MT8. ATTEMPTS WERE UNSUCCESSFUL AT REMOVING THE MARKER BAND INTRAVASCULARLY AND IT WAS REMOVED SURGICALLY.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 25279838 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE ARTIX SYSTEM OF DEVICES. THE PATIENT HAD A LEFT SIDE FEM-POP BYPASS GRAFT THAT CONTAINED CLOT THAT HAD REQUIRED PRIOR TREATMENT. RIGHT CFA ACCESS OBTAINED AND THE INTRODUCER SHEATH PLACED. IMAGING TAKEN NOTED THAT THE ENTIRE GRAFT WAS FULL OF CLOT. THE STRYKER 65CM SHEATH WAS PREPPED AND PLACED IN LEFT CFA. THE WIRE WAS EXCHANGED FOR A SPIDER WIRE/FILTER 0.014 WIRE WITH FILTER PROXIMAL TO POPITEAL ARTERY. THE FUNNEL SHEATH WAS PREPPED AND FUNNEL PLACED WITHIN 2CM NUB OF GRAFT TO PROTECT THE PROFUNDA ARTERY. THE ARTIX MT SHEATH WAS PREPPED BASED ON SIZING OF GRAFT AT 8MM DIAMETER. MULTIPLE PASSES WERE PERFORMED, YIELDING ACUTE, SUBACUTE AND CHRONIC CLOT. THE DECISION WAS MADE TO ANGIOPLASTY THE GRAFT AND RE-APPLY REMAINING CLOT TO SIDES OF GRAFT. THE FUNNEL CATHETER WAS RE-CAPTURED UNDER ASPIRATION. DURING MECHANICAL PASSES THE MECHANICAL ELEMENT HAD DECENT RESISTANCE COME MID GRAFT. IT WAS IDENTIFIED THAT A SMALL CLOT MANEUVERED INTO THE PERONEAL ARTERY. WE REMOVED THE SPIDER WIRE, WIRED THE PERONEAL AND BALLOONED THE PERONEAL AND ACHIEVED PATENCY. WE ALSO WIRED THE HIBERNATING PT AND AT AND OPENED THOSE ARTERIE

  Patient problems: Vascular Dissection

  MAUDE report 24689936 ↗
• InjuryFeb 19, 2026Entrapment of Device

  ON (B)(6) 2026, A 48 YEAR OLD FEMALE UNDERWENT LOWER RIGHT EXTREMITY BYPASS THROMBECTOMY USING STRYKER DEVICES. INITIAL PASSES WITH THE ARTIX MT8 WERE SUCCESSFUL. FOLLOWING BALLOON ANGIOPLASTY, THE CATHETER BECAME ENTRAPPED DURING THE FIFTH PASS. BAILOUT AND MITIGATION TECHNIQUES WERE ATTEMPTED WITHOUT SUCCESS. A DECISION WAS MADE TO REMOVE THE ENTIRE SYSTEM. DURING WITHDRAWAL, THE CATHETER BECAME STUCK AT THE PUNCTURE SITE. THE PHYSICIAN ELECTED TO CONVERT THE PUNCTURE SITE TO AN OPEN CUTDOWN FOR DEVICE REMOVAL. UPON PERFORMING THE CUTDOWN AND EXTRACTING THE DEVICE, IT WAS NOTED THE CATHETER CONTAINED LARGE, CHRONIC THROMBUS. AFTER DEVICE REMOVAL, THE PHYSICIAN FOUND REDUCED FLOW TO THE RIGHT LOWER EXTREMITY DUE TO VESSEL INJURY AT THE ACCESS SITE. THE PHYSICIAN THEN PERFORMED AN EXTENDED CUTDOWN, WHICH REVEALED A DISSECTION AT THAT LOCATION. THE DISSECTION WAS REPAIRED AND THE SITE WAS SURGICALLY CLOSED.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 24397414 ↗
• InjuryJan 29, 2026Migration or Expulsion of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT AN ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PREEXISTING STENTS IN THEIR RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) PLACED THREE MONTHS PRIOR AND THE PATIENT'S RIGHT LEG WAS NO LONGER FUNCTIONAL. VISUAL INSPECTION OF THE STENTS USING ANGIOGRAPHY AND FLUOROSCOPY REVEALED THE STENTS WERE OVERLAPPING AND STENTED MOST OF THE PATIENT'S SFA. THERE WAS NO BLOOD FLOW OBSERVED INSIDE OF THE PATIENT'S STENTS. THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS PLACED AND THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT8) WAS ADVANCED THROUGH THE ARTIX SHEATH TO THE MID SFA. CLOT WAS REMOVED AFTER ONE PASS WITH THE MT8 AND NO NOTED STENT INTERACTION OCCURRED. EIGHT MORE PASSES WERE COMPLETED AND AN ANGIOGRAM REVEALED LIMITED FLOW THROUGH THE STENTED AREA. THE MEDICAL TEAM THEN ATTEMPTED TO COMPLETE A PASS FROM THE MIDDLE OF THE STENT WHERE RESISTANCE WAS MET AND EXTRA FORCE WAS USED TO RETRACT THE MT8. UNDER FLUOROSCOPY, THE MEDICAL TEAM VISUALIZED THE MIDDLE STENT MIGRATED INTO THE PROXIMAL STENT AND NOTICED METAL POKING OUT OF THE MT8 CORING ELEMENT WHEN THE DEVICE WAS REMOVED. WITH FURTHER ASSESSMENT, THE METAL PIECE APPEARED TO BE A PART OF THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218118 ↗
• InjuryNov 20, 2025Migration; Migration

  ON (B)(6) 2025, A PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PREEXISTING, OVERLAPPING STENTS IN THEIR RIGHT SUPERFICIAL FEMORAL ARTERY, EXTENDING TO THEIR POPLITEAL ARTERY, THAT WERE PLACED THREE YEARS PRIOR. THE PATIENT'S CLOT AGE WAS ESTIMATED AT FIVE DAYS. DURING THE THROMBECTOMY, THE ARTIX MT THROMBECTOMY DEVICE (ARTIX MT8) CAUGHT ON THE DISTAL END OF THE PATIENT'S PREEXISTING STENT AND DISPLACED THE STENT 3-4 CENTIMETERS. THE ARTIX MT8 WAS REMOVED WITHOUT ISSUES AND THE PHYSICIAN RE-LINED THE PATIENT'S STENT WITH A COVERED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610644 ↗
• InjuryOct 22, 2025Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD UNDERGONE A PERCUTANEOUS TRANSMURAL ARTERIAL BYPASS (PTAB) ONE WEEK PRIOR. THE PATIENT HAD A PREEXISTING STENT IN THE LEFT SUPERFICIAL AND LEFT POPLITEAL ARTERIES AND A BYPASS GRAFT IN THE LEFT SUPERFICIAL ARTERY. THE PATIENT HAD CLOT IN THEIR LEFT POPLITEAL AND LEFT SUPERFICIAL FEMORAL ARTERIES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT FOUR DAYS. TWO SUCCESSFUL PASSES WERE COMPLETED USING THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT8) THEN DURING THE THIRD PASS, THE MT8 BECAME CAUGHT ON THE PATIENT'S PREEXISTING STENT AND SIGNIFICANT RESISTANCE WAS FELT WHEN TRYING TO RETRACT THE DEVICE. THE PHYSICIAN USED SIGNIFICANT FORCE TO REMOVE THE MT8 AND UPON REMOVAL, THE ARTIX CORING ELEMENT HAD SEPARATED FROM THE CATHETER AND REMAINED IN THE PATIENT'S VESSEL. AN ENDARTERECTOMY WAS PERFORMED WHICH SUCCESSFULLY REMOVED THE MT8 CORING ELEMENT AND THE PATIENT'S PROXIMAL PREEXISTING STENT. THE PATIENT WAS DOING WELL POST-ENDARTERECTOMY AND DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 23363780 ↗
• InjuryApr 2, 2025Use of Device Problem; Use of Device Problem

  A (B)(6) FEMALE UNDERWENT A THROMBECTOMY WITH THE INARI ARTIX SYSTEM. FOUR PASSES WERE PERFORMED BUT A PERFORATION OCCURRED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. IT IS SPECULATED THAT THE ARTIX MT8 WENT THROUGH A CALCIFIED SECTION. A VIABAHN STENT WAS USED TO COVER THE INJURY, AND THE PATIENT EXPERIENCED NO OTHER SIDE EFFECTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Great Vessel Perforation

  MAUDE report 21757397 ↗