InThrill Sheath 53-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850291007369), received between Aug 6, 2025 and Nov 7, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Use of Device Problem; Use of Device Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT UPPER EXTREMITY DEEP VEIN THROMBOSIS THROMBECTOMY USING INARI DEVICES. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ANGLING THE INTHRILL SHEATH DUE TO THE PATIENT'S PREEXISTING ARTERIOVENOUS GRAFT. CONTRAST EXTRAVASATION WAS NOTICED ON FLUOROSCOPY AROUND THE ANASTOMOSIS. THE EXTRAVASATION WAS TREATED WITH IMPLANTING A STENT GRAFT. FINAL IMAGING SHOWED GOOD BLOOD FLOW THROUGH THE GRAFT.

  Patient problems: Extravasation

  MAUDE report 23500024 ↗
• InjuryAug 6, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  A PATIENT UNDERWENT A THROMBECTOMY TO ADDRESS THEIR LEFT UPPER EXTREMITY DEEP VEIN THROMBOSIS WITH THE INTHRILL THROMBECTOMY CATHETER. AFTER MULTIPLE PASSES WERE PERFORMED, THE PHYSICIAN BEGAN TO REMOVE THE SHEATH TO FLUSH. HOWEVER, THE SHEATH WAS PULLED WITHOUT RE-SHEATHING THE FUNNEL WHICH RESULTED IN THE BRACHIAL VEIN BEING PULLED OUT OF THE ACCESS SITE. THE VEIN WAS LIGATED AND THE FINAL VENOGRAM WAS PERFORMED WHICH SHOWED FULL PATENCY.

  Patient problems: Vascular Dissection

  MAUDE report 22734123 ↗