JETi™ WV6203ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648351396), received between Feb 28, 2023 and Apr 12, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 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.

• MalfunctionApr 12, 2023Increase in Pressure; Contamination /Decontamination Problem; Increase in Pressure; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE JETI ASPIRATION DEVICE WAS UNABLE TO BE PREPPED. AFTER PRIMING THE SYSTEM, IT WOULD NOT ADVANCE TO THE NEXT STEP AND AN ERROR OCCURRED. A HIGH PRESSURE ALERT. THERE WAS NO DAMAGE NOTED TO THE CATHETER AND ALL CONNECTIONS TO THE PUMP WERE TIGHTLY SET. NO KINKS IN THE TUBING WERE NOTED. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. AFTER THE CASE. THE SALINE DRIVE UNIT (SDU) AND PUMP SET WERE TESTED WITH A DEMO CATHETER AND THE SDU AND PUMP SET WORKED APPROPRIATELY. RETURNED DEVICE. ANALYSIS NOTED DEVICE CONTAMINATION APPEARING TO BE FILTER MATERIAL, PLUGGING THE SALINE ORIFICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728253 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING THE JETI DEVICE IN THE LEFT FEMORAL POPLITEAL BYPASS GRAFT. DURING THE PROCEDURE, THE PATIENT LOST 300 ML OF BLOOD. ON (B)(6) 2023 THE PATIENT EXPERIENCED A LOW HEMOGLOBIN/HEMATOCRIT (H&H), BUT NO ACTUAL SOURCE FOR THE BLEEDING WAS IDENTIFIED VIA CT OF THE ABDOMEN/ PELVIS. THE PATIENT WAS TRANSFUSED WITH TWO UNITS PACKED RED BLOOD CELLS (PRBC). PER THE PHYSICIAN, THERE WAS NO DEVICE MALFUNCTION AND THE JETI CATHETER DID NOT CAUSE DIRECT INJURY TO THE PATIENT; HOWEVER, THE JETI SYSTEM WORKS TO EXTRACT BLOOD, AND ALTHOUGH THE DEVICE PERFORMED AS EXPECTED, THERE MAY BE A CAUSAL RELATIONSHIP BETWEEN THE JETI SYSTEM AND THE LOW H&H. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Anemia

  MAUDE report 16453776 ↗