Artix Thin-Walled Sheath 30-104 / AS-01206Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810123710577), received between Jul 9, 2025 and Nov 25, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 59-YEAR-OLD FEMALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 14 DAYS. DURING THE PROCEDURE, CLOT WAS REMOVED ON THE RIGHT AFTER SEVEN PASSES WITH THE THE ARTIX MECHANICAL THROMBECTOMY DEVICE (MT6) AND A STENT WAS PLACED IN THE RIGHT ILIAC ARTERY. WHILE COMPLETING FLUOROSCOPY, SOME CLOT WAS EMBOLIZED AS A RESULT OF BALLOONING. ONE MORE PASS USING THE MT6 REMOVED THE EMBOLIZED CLOT. IMAGING CONFIRMED NORMAL FINDINGS. ALL DEVICES WERE REMOVED THROUGH THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH), HOWEVER UPON REMOVAL OF THE DILATOR, THE DILATOR WOULD NOT RETRACT. THE PHYSICIAN PULLED THE ARTIX SHEATH AND THE SHEATH CAME APART IN A SECTION. THE PHYSICIAN MOVED CLOSER TO THE ACCESS AND PULLED AGAIN, WHICH RESULTED IN ANOTHER TEAR IN THE SHEATH. THE PHYSICIAN USED HEMOSTATS AND INCREASED THE DILATION OF THE SITE, AND EVERYTHING WAS FULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648552 ↗
• InjuryNov 19, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  ON (B)(6) 2025, A 79-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT HAD A PREEXISTING STENT IN THE RIGHT SUPERFICIAL ARTERY. THE PATIENT¿S CLOT AGE WAS ESTIMATED AT SEVEN DAYS, AND THE OCCLUSION WAS IN THE PATIENT¿S RIGHT SUPERFICIAL ARTERY. UPON COMPLETION OF THE THROMBECTOMY, A BALLOON WAS INSERTED INTO THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) FOR POST-THROMBECTOMY ANGIOPLASTY. A LOT OF TENSION WAS NOTED UPON INITIALLY DEPLOYING THE ARTIX SHEATH. WHILE THE PHYSICIAN WAS BALLOONING, THE PHYSICIAN PULLED BACK ON THE ARTIX SHEATH AND THE SHEATH UNRAVELED AND COLLAPSED ON THE INFLATED BALLOON. THIS PREVENTED THE BALLOON FROM DEFLATING AND WAS SUBSEQUENTLY STUCK WITHIN THE SHEATH. THE PHYSICIAN PERFORMED AN ARTERIAL CUTDOWN AND WAS ABLE TO SUCCESSFULLY REMOVE BOTH THE ARTIX SHEATH AND BALLOON.

  Patient problems: Vascular Dissection

  MAUDE report 23598169 ↗
• InjurySep 10, 2025Entrapment of Device; Difficult to Remove; Material Separation; Entrapment of Device; Difficult to Remove; Material Separation

  ON (B)(6) 2025, A 69-YEAR-OLD MALE PATIENT UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 20 DAYS. AT THE END OF THE THROMBECTOMY, WHILE REMOVING THE ARTIX THIN-WALLED SHEATH, WITHOUT THE DILATOR, RESISTANCE WAS FELT, WHICH RESULTED IN THE DEVICE BECOMING STUCK. AN ATTEMPT WAS MADE TO INSERT THE DILATOR, HOWEVER THE DILATOR WOULD NOT ADVANCE. FLUOROSCOPY SHOWED THE MARKER BAND HAD SEPARATED AND WAS CAUGHT AROUND THE AORTIC BIFURCATION. AN ARTERIAL CUTDOWN WAS PERFORMED TO RETRIEVE THE MARKER BAND, WHICH WAS SUCCESSFUL.

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

  MAUDE report 23022265 ↗
• MalfunctionJul 9, 2025Material Separation; Material Separation

  ON (B)(6) 2025, A 47-YEAR-OLD MALE UNDERWENT ARTERIAL THROMBECTOMY USING INARI DEVICES. THE PATIENT'S CLOT AGE WAS ESTIMATED AT 60 DAYS. AFTER DEPLOYING THE ARTIX FUNNEL CATHETER, THE RADIOPAQUE MARKER ON THE DISTAL END OF THE ARTIX THIN-WALLED SHEATH (ARTIX SHEATH) SEPARATED FROM THE SHEATH. THE MARKER REMAINED ON THE GUIDEWIRE. THE PHYSICIAN USED A BIOPSY CATHETER TO SUCCESSFULLY RETRIEVE AND REMOVE THE MARKER BAND FROM THE PATIENT'S VASCULATURE. UPON INSPECTION OF THE MARKER BAND, THERE WAS A CLEAN BREAK, AND NO TEARING OR UNRAVELING WAS OBSERVED. THE CASE CONTINUED, AND NEARLY ALL THE CLOT WAS REMOVED FROM THE PATIENT'S PREEXISTING STENT. THE PATIENT HAD FULL FLOW RESTORED AFTER THE THROMBECTOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460393 ↗

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