Jade PTA Balloon Dilatation Catheter 586024022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934955901386), received between Aug 27, 2024 and Sep 6, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 6, 2024Material Rupture; Material Separation; Material Rupture; Material Separation

  DURING PROCEDURE USING A JADE BALLOON INSIDE A STENT IN SUPERFICIAL FEMORAL ARTERY (SFA), THE BALLOON RUPTURED DURING RETRIEVAL WHEN THE BALLOON GOT STUCK ON THE STRUT OF THE STENT AND GOT DEFLATED. IT RIPPED THE BALLOON IN HALF. THE DISTAL TIP OF THE BALLOON WAS RETRIEVED USING A SNARE. NO FRAGMENTS WERE LEFT IN-VIVO. THE BALLOON WAS NOT INFLATED AT ALL. THERE WAS CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE. THE PATIENT WAS STABLE, AND A REPLACEMENT BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156193 ↗
• MalfunctionSep 3, 2024Material Separation; Material Separation

  DURING PROCEDURE USING A JADE BALLOON INSIDE A STENT IN SUPERFICIAL FEMORAL ARTERY (SFA), THE BALLOON POPPED DURING RETRIEVAL WHEN THE BALLOON GOT STUCK ON THE STRUT OF THE STENT AND GOT DEFLATED. IT RIPPED THE BALLOON IN HALF. THE DISTAL TIP OF THE BALLOON WAS RETRIEVED USING A SNARE. NO FRAGMENTS WERE LEFT IN THE PATIENT'S BODY. ADDITIONAL INFORMATION: THE BALLOON WAS NOT ABLE TO BE INFLATED. PATIENT IS FINE. A REPLACEMENT BALLOON WAS USED WITH NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20122974 ↗
• InjuryAug 27, 2024Material Rupture; Material Rupture

  A JADE BALLOON RUPTURED IN-VIVO AFTER TREATMENT OF A 80% STENOSED, SEVERELY CALCIFIED, 6MM MID SUPERFICIAL FEMORAL ARTERY. A PIECE OF THE BALLOON WAS LEFT IN THE PATIENT. A SNARE WAS USED TO RETRIEVE THE FRACTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077023 ↗