JETi™ WV8803ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648351402), received between Jul 26, 2023 and Feb 28, 2025 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionFeb 28, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE JETI THROMBECTOMY 8F KIT WAS PREPARED BUT WAS NOT HOLDING SUCTION. IT WAS SUCKING AIR. THE CATHETER WAS NOT YET IN THE PATIENT WHEN THIS OCCURRED. ANOTHER JETI 8F KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21491037 ↗
• MalfunctionApr 5, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT AN OCCLUDED AORTIC GRAFT IN THE ILIAC ARTERY. THE 8FR JETI HYDRODYNAMIC THROMBECTOMY CATHETER PASSED THROUGH THE OCCLUDED SEGMENT TWO TIMES. ANGIOGRAPHY SHOWED THE LEFT LIMB WAS PATENT. BALLOON ANGIOPLASTY WAS PERFORMED IN TWO AREAS OF RESIDUAL STENOSIS. AN ANGLED CATHETER PASSED THROUGH THE AORTA TO PERFORM THE FINAL ANGIOGRAPHY RUNS WHEN IT WAS NOTED THE IMPLANTED STENT HAD MIGRATED FROM THE LEFT COMMON ILIAC AND WAS FREE FLOATING IN THE AORTA. PER THE PHYSICIAN, IT IS UNKNOWN IF THE JETI CATHETER OR THE ANGLED CATHETER CAUSED THE STENT TO DISLODGE AND MIGRATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052419 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE JETI HYDRODYNAMIC THROMBECTOMY SYSTEM WAS USED IN THE RIGHT FEMORAL VEIN. AFTER REMOVING THE JETI CATHETER, AN IMAGE WAS TAKEN THROUGH THE SHEATH WITH CONTRAST WHEN A PERFORATION WAS NOTED IN THE PATIENT¿S RIGHT POPLITEAL VEIN. THE PHYSICIAN PULLED THE SHEATH AND HELD MANUAL PRESSURE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 18708012 ↗
• MalfunctionJul 26, 2023Expiration Date Error; Expiration Date Error

  RETURNED DEVICE ANALYSIS OF THE JETI DISPOSABLE KIT REVEALED THAT THE OUTER PACKAGE OF THE JETI STERILE DISPOSABLE KIT HAD AN EXPIRATION DATE OF 08/16/2024; HOWEVER, ONE COMPONENT, THE PUMP SET (J-SET), HAD AN EXPIRATION DATE OF 04/20/2023. THE TWO ADDITIONAL COMPONENTS, HAD THE FOLLOWING EXPIRATION DATES: SUCTION TUBING (WVHAND) HAD AN EXPIRATION DATE OF 9/14/2024 AND THE CATHETER (WV088F) HAD AN EXPIRATION OF 08/16/2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398384 ↗