Jade PTA Balloon Dilatation Catheter 595015022Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 06934955903786), received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A PREVIOUSLY STENTED SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOT CALCIFIED AS IT WAS STENTED. AN ABBOTT WHISPER WIRE WAS ADVANCED, AND LASER TREATMENT WAS PERFORMED. AN ABBOTT ARMADA BALLOON WAS ADVANCED AND INFLATED TO AN UNKNOWN ATMOSPHERIC PRESSURE BUT RUPTURED. A JADE BALLOON WAS ADVANCED AND INFLATED TO 14 ATM PRESSURE AND RUPTURED. DURING AN ATTEMPT TO REMOVE THE JADE BALLOON, THE JADE BALLOON CATHETER FRACTURED WHEN IT REACHED THE PROXIMAL PART OF THE STENT. THE SHAFT AND HALF OF THE JADE BALLOON WAS REMOVED BUT THE DISTAL PART OF THE JADE BALLOON REMAINED IN VIVO BUT WAS STILL ON THE GUIDE WIRE. WHILE TRYING TO RETRIEVE THE DISTAL PART OF THE JADE BALLOON, THE WIRE WAS ACCIDENTALLY PULLED OUT OF POSITION, LEAVING THE DISTAL PART OF THE BALLOON IN VIVO. ATTEMPTS TO REWIRE THE SFA WITH A WHISPER WIRE, VIPER WIRE, ASTATO WIRE WERE ALL UNSUCCESSFUL. THE DISTAL PART OF THE JADE BALLOON WAS LEFT IN VIVO. THE PROCEDURE WAS DEEMED COMPLETED AND THE PATIENT WAS STABLE. IT IS REPORTED THERE WAS NO COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20045413 ↗