JETi Peripheral Catheter WV008FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B139WV008F0), received between Aug 14, 2018 and Aug 31, 2018 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (2 reports).

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.

• DeathAug 31, 2018Off-Label Use; Off-Label Use

  AN ADVERSE EVENT OCCURRED WHILE USING THE JETI PERIPHERAL THROMBECTOMY SYSTEM IN (B)(6), USA. THE PATIENT WAS TREATED FOR PULMONARY EMBOLISM AND CRASHED APPROXIMATELY 10-15 MINUTES INTO THE INTERVENTIONAL PORTION OF THE PROCEDURE. THE PATIENT WAS INTERMITTENTLY RECOVERED SEVERAL TIMES. HOWEVER, THE PATIENT ULTIMATELY EXPIRED WITHIN THE OPERATING ROOM.

  Patient problems: Death

  MAUDE report 7839703 ↗
• InjuryAug 14, 2018Off-Label Use; Off-Label Use

  AN ADVERSE EVENT OCCURRED AFTER USING THE JETI PERIPHERAL THROMBECTOMY SYSTEM IN (B)(6) USA. WHEN THE OCCLUSION COULD NOT BE COMPLETELY REMOVED WITHIN THE INFERIOR VENA CAVA OF THE PATIENT, AN ALTERNATIVE DEVICE (ARGON CLEANER) WAS UTILIZED AND THE PATIENT ENTERED BRADYCARDIA APPROXIMATELY 10 MINUTES INTO THE ALTERNATIVE PROCEDURE.

  Patient problems: Bradycardia

  MAUDE report 7782233 ↗