Jade PTA Balloon Dilatation Catheter 596024022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934955903953), received between Sep 2, 2025 and Sep 4, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 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.

• InjurySep 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDIONED. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22968736 ↗
• InjurySep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8 ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDION. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22948898 ↗
• InjurySep 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE; THE JADE BALLOON WAS INFLATED IN MID SUPERFICIAL FEMORAL ARTERY (SFA) TO 8 ATM AND IT RUPTURED. THE PHYSICIAN ATTEMPTED TO PULL THE BALLOON OUT OF THE SFA OVER THE WIRE AND IT COULD NOT MOVE, IT JUST ACCORDION. THE PEDAL ACCESS WAS OBTAINED IN AN ATTEMPT TO CAPTURE BALLOON WITH A SNARE. SOME OF THE BALLOON WAS SNARED OUT AND A STENT WAS PLACED TO ADHERE THE LEFTOVER BALLOON TO THE ARTERY WALL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22948897 ↗