Artix MTRecalls & reported problems across all models
Inari Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Artix MT model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 1
We found 2 models of Artix MT by Inari Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2025 and May 26, 2026 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Entrapment of Device” (4 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Artix MT recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 8, 2025Open, 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 Artix MT problems
Device problems
- Entrapment of Device4
- Migration3
- Detachment of Device or Device Component2
- Adverse Event Without Identified Device or Use Problem1
- Material Separation1
- Migration or Expulsion of Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Vascular Dissection3
- Device Embedded In Tissue or Plaque2
- Obstruction/Occlusion2
- Great Vessel Perforation1
- Insufficient Information1
Artix MT models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Artix MT 32-102 / AS-01248Catheter, Continuous Flush1 recall4 reports
- Artix MT 32-103 / AS-01244Peripheral Mechanical Thrombectomy With Aspiration7 reports
Recent Artix MT adverse event reports
The 11 most recent reports across all models, 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 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 ↗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 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 ↗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 ↗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 ↗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 ↗
Other Inari Medical, Inc. products
All Inari Medical, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page