JETi™ WVSDUPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648351365), received between Nov 29, 2022 and Feb 2, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2023Loose or Intermittent Connection; Electrostatic Discharge; Power Problem; Loose or Intermittent Connection; Electrostatic Discharge; Power Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE, TO REMOVE THROMBUS FROM THE POPLITEAL TO LEFT FEMORAL VEIN. THE JETI ASPIRATION SALINE DRIVE UNIT (SDU) WAS USED. INITIALLY, THE SDU WAS WORKING APPROPRIATELY; HOWEVER, DURING USE, THE SDU TURNED OFF. IT WAS NOTED THAT THE POWER CORD THAT PLUGS INTO THE SDU CONNECTION WAS LOOSE. IT WAS PUSHED BACK IN, THE SYSTEM WAS TURNED BACK ON, AND THE DEVICE WORKED APPROPRIATELY DURING THE REST OF THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. AFTER THE PROCEDURE, TROUBLESHOOTING WAS PERFORMED ON THE SDU. THE SDU WAS PLUGGED IN AND TURNED ON. THE POWER CORD WAS LOOSED AND WAS PUSHED IN; THE DEVICE BEGAN TO SPARK. THE DEVICE WAS NOT BEING USED IN A PROCEDURE AT THIS TIME, SO THERE WAS NO PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16287903 ↗
• MalfunctionDec 6, 2022Decrease in Pressure; No Apparent Adverse Event; Decrease in Pressure; No Apparent Adverse Event

  IT WAS REPORTED THE JETI SALINE DRIVE UNIT (SDU) WAS NOT FUNCTIONING PROPERLY AS THE HIGHEST NEGATIVE PRESSURE WAS 25. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924184 ↗
• MalfunctionNov 29, 2022Incorrect, Inadequate or Imprecise Result or Readings; Suction Problem; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; Suction Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING DEMONSTRATION USE DURING A CONFERENCE, THE JETI SALINE DRIVE UNIT (SDU) WAS USED. DURING DEMO USE, THE DEMO THROMBUS WAS PUSHED AWAY, RATHER THAN BEING ASPIRATED. THIS WAS A NEW OCCURRENCE, NOT HAVING HAPPENED DURING PATIENT USE, AND THERE WAS NO PATIENT INVOLVEMENT, AS THIS WAS DEMO USE. A FEW DAYS LATER, THE JETI SDU WAS TESTED, AND THE ASPIRATION NUMBERS STAYED IN THE LOW 20'S RATHER THAN 26-30 AS EXPECTED. IT WAS BELIEVED THAT THERE WAS AN ISSUE WITH THE SDU AND REPLACEMENT WAS REQUESTED. THERE WAS NO PATIENT INVOLVEMENT WITH EITHER OF THESE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15882909 ↗