Artix Thin-Walled Sheath 30-103 / AS-01216Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810123710560), received between Mar 27, 2025 and Sep 30, 2026 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K241894); they may or may not involve this specific model.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Entrapment of Device; Fracture

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50949928 ↗
• MalfunctionSep 30, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948042 ↗
• InjuryJul 30, 2026Material Separation

  A patient underwent a thrombectomy with the Artix system of devices on (b)(6) 2026. Mid procedure, the Artix sheath separated at the junction of the hemostasis valve and became stuck in the body. The funnel catheter remained inside the sheath. This was noticed under fluoro imaging and confirmed by seeing the funnel catheter outside of body. Removing the device required bilateral cutdowns. The patient was then treated with a different intervention.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50087073 ↗
• MalfunctionMay 29, 2026Leak/Splash; Material Separation

  ON (B)(6) 2026, A 67-YEAR-OLD MALE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE ARTRIX SYSTEM OF DEVICES. DURING REMOVAL OF THE DEVICE THE SHEATH FAILED AT THE DISTAL PORTION. ADDITIONAL SURGERY WAS PERFORMED TO RETRIEVE SHEATH TIP AND SHEATH.

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

  MAUDE report 25337903 ↗
• InjuryMar 20, 2026Entrapment of Device; Material Separation

  ON (B)(6) 2026, A PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING STRYKER PERIPHERAL VASCULAR DEVICES. AT THE END OF THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO REMOVE THE SHEATH. AS THE PHYSICIAN PULLED THE SHEATH, THE SHEATH UNRAVELED. AN ARTERIAL CUTDOWN WAS PERFORMED TO REMOVE THE SHEATH.

  Patient problems: Vascular Dissection

  MAUDE report 24651241 ↗
• InjuryMar 5, 2026Entrapment of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING THE INARI ARTIX SYSTEM. AFTER COMPLETION OF THE THROMBECTOMY PORTION OF THE PROCEDURE, THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT8) WAS SUCCESSFULLY REMOVED AND A SUPERA STENT WAS INSERTED INTO THE PATIENT'S RIGHT LEG. THE STENT ELONGATED UPON DEPLOYMENT, WHICH RESULTED IN THE STENT BEING EXTENDED INTO THE ARTIX FUNNEL CATHETER. THE ARTIX FUNNEL CATHETER AND ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WOULD NOT RELEASE THE STENT. THE SUPERA STENT CATHETER THEN BROKE UPON RETRACTION, LEAVING THE DISTAL CATHETER TRAPPED ON THE GUIDEWIRE WITHIN THE FUNNEL CATHETER AND ARTIX SHEATH. THE PHYSICIAN ADVANCED THE ARTIX SHEATH TO REMOVE THE FUNNEL CATHETER AND RESISTANCE WAS NOTED. THE PHYSICIAN THEN INSERTED THE DILATOR AND THE DISTAL TIP OF THE STENT DELIVERY SYSTEM ADVANCED DISTALLY AND BECAME VISIBLE. THE PHYSICIAN ATTEMPTED TO REMOVE THE SUPERA STENT DELIVERY SYSTEM; HOWEVER, WAS UNABLE TO REMOVE THE SYSTEM WITHOUT FORCE, THEREFORE THE DECISION WAS MADE TO TRANSFER THE PATIENT TO SURGERY TO PERFORM A CUTDOWN TO REMOVE THE STENT SYSTEM, THE FUNNEL CATHETER, AND ARTIX SHEATH.

  Patient problems: Vascular Dissection

  MAUDE report 24526865 ↗
• MalfunctionJan 22, 2026Material Separation

  ON (B)(6) 2025, A 86 YEAR OLD FEMALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS 2 DAYS OLD. DURING THE THROMBECTOMY, THE ARTIX FUNNEL CATHETER (FUNNEL CATHETER) UNRAVELED AT THE HUB UPON REMOVAL. A HEMOSTAT WAS REQUIRED TO REMOVE THE PORTION OF THE CATHETER THAT REMAINED IN THE PATIENT'S BODY. THERE WERE NO REPORTED INJURIES AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147468 ↗
• MalfunctionJan 13, 2026Material Separation

  ON (B)(6) 2025, A 66-YEAR-OLD FEMALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS 30 DAYS. DURING THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) STARTED TO UNRAVEL AND SEPARATE FROM THE REST OF THE DEVICE DURING REMOVAL. THE SEPARATED SHEATH HAD TO BE REMOVED WITH A BALLOON. THERE WERE NO REPORTED INJURIES AND THE CASE WAS COMPLETED WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063615 ↗
• InjuryDec 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 20925, A MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. DURING THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) AND THEN THE ARTIX FUNNEL CATHETER WAS INSERTED VIA THE ARTIX SHEATH. TWO ASPIRATIONS WERE PERFORMED WITH NO CLOT REMOVED. AN ATTEMPT WAS MADE TO EXCHANGE THE GUIDEWIRE; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE ARTIX FUNNEL CATHETER WAS RETRACTED BACK INTO THE ARTIX SHEATH. ON IMAGING, THE MEDICAL TEAM NOTICED THE RADIOPAQUE MARKER REMAINED AT THE PATIENT'S FEMORAL ARTERY. THE ARTIX SHEATH AND ARTIX FUNNEL CATHETER WERE REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM FOR AN ARTERIAL CUTDOWN TO REMOVE THE MARKER BAND.

  Patient problems: Vascular Dissection

  MAUDE report 23846451 ↗
• InjuryDec 11, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 73-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A HISTORY OF MULTIPLE PROCEDURES AT THE GROIN SITE, WHICH RESULTED IN NOTABLE SCAR TISSUE AT THE ACCESS SITE. DURING THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) BECAME STUCK IN THE PATIENT'S VASCULATURE AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE ARTIX SHEATH, THE DEVICE SEPARATED. THE PHYSICIAN WAS ABLE TO REMOVE THE ARTIX SHEATH BY PERFORMING AN ARTERIAL CUTDOWN IN THE CATHETERIZATION LABORATORY.

  Patient problems: Vascular Dissection

  MAUDE report 23783998 ↗
• MalfunctionMay 22, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ON (B)(6) 2025, A MALE PATIENT UNDERWENT RIGHT LOWER EXTREMITY ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A HISTORY OF PERIPHERAL ARTERY DISEASE AND HAD A PREEXISTING STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND A BYPASS GRAFT IN THE RIGHT COMMON FEMORAL AND POPLITEAL ARTERIES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT TWO DAYS. THE TARGET TREATMENT AREA WAS IN THE RIGHT POPLITEAL AND TIBIAL ARTERIES. AT THE END OF THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH UNRAVELED UPON EXITING THE PATIENT'S LEFT COMMON FEMORAL ARTERY. A STIFF ANGLED GLIDEWIRE WAS PLACED THROUGH THE PORTION OF THE SHEATH THAT REMAINED IN THE PATIENT'S BODY AND A HEMOSTAT WAS USED TO REMOVE THE REMAINING PORTION OF THE SHEATH COMPLETELY. THE CASE WAS CONCLUDED WITHOUT FURTHER ISSUES AND THE PATIENT HAD FULL FLOW RESORTED POST-THROMBECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073671 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A FEMALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD PRE-EXISTING STENTS IN THE LEFT COMMON ILIAC AND LEFT SUPERFICIAL FEMORAL ARTERIES AND PREEXISTING BYPASS GRAFTS IN THE LEFT SUPERFICIAL FEMORAL AND LEFT PERONEAL ARTERIES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT EIGHT DAYS. DURING THE THROMBECTOMY, RESISTANCE WAS FELT WHEN THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) WAS ADVANCED TO THE PATIENT'S LEFT SIDE ARTERIES. IT WAS BELIEVED THE ARTIX SHEATH WAS CAUGHT ON A STRUT OF THE PATIENT'S PREEXISTING STENT. WHEN THE ARTIX SHEATH WAS RETRACTED, THE MARKER BAND HAD SEPARATED FROM THE DEVICE. THE PHYSICIAN INFLATED A BALLOON INSIDE OF THE RADIOPAQUE MARKER BAND AND REMOVED THE BAND AND BALLOON FROM THE PATIENT'S BODY WITHOUT ISSUE. A NEW DEVICE WAS USED, AND THE CASE WAS COMPLETED WITHOUT ANY ADDITIONAL ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22071142 ↗
• MalfunctionMar 27, 2025Entrapment of Device; Difficult to Remove; Material Separation; Device Damaged by Another Device; Migration; Entrapment of Device; Difficult to Remove; Material Separation; Device Damaged by Another Device; Migration

  ON (B)(6) 2025 A 58-YEAR-OLD MALE PATIENT UNDERWENT LEFT LOWER EXTREMITY (LLE) ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PRE-EXISTING STENT IN THE LEFT POPLITEAL ARTERY THAT WAS PLACED APPROXIMATELY ONE YEAR PRIOR. DURING THE THROMBECTOMY, THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) ACCESSED THE TREATMENT LOCATION THROUGH THE PATIENT'S RIGHT COMMON FEMORAL ARTERY. DURING A PASS WITH THE ARTIX MECHANICAL THROMBECTOMY CATHETER (MT), THE MT BECAME STUCK ON THE PATIENT'S PRE-EXISTING STENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY DISLODGE THE MT FROM THE STENT BY USING FORCE TO PULL THE CATHETER. THE MT WAS UNABLE TO COLLAPS INTO THE ARTIX FUNNEL CATHETER (FUNNEL CATHETER) AND BOTH THE MT AND FUNNEL CATHETER WERE REMOVED IN TANDEM THROUGH THE ARTIX SHEATH. UPON REMOVAL OF THE MT, IT WAS NOTED STENT FRAGMENTS WERE CAPTURED IN THE COLLECTION BAG. A 6FR TERUMO DESTINATION SHEATH WAS INTRODUCED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) TO RETRIEVE THE REMAINING STENT PIECE THAT WAS DISTAL TO THE ARTIX SHEATH. UPON COMPLETION OF THE CASE, THE TERUMO DESTINATION SHEATH BECAME STUCK IN THE ARTIX SHEATH. THE ARTIX SHEATH BECAME KINKED AND UNCOUPLING WAS OBSERVED DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712038 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K241894. One submission often covers many models, so check the product and lot details in each record.

• Z-1728-2025 · Apr 8, 2025 · Open, Classified
  Artix MT Thrombectomy Device, REF: 32-102