Jade PTA Balloon Dilatation Catheter 585015022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955901270), received between Mar 29, 2025 and Apr 4, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT A NON-DILATABLE, HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION WAS ATTEMPTED TO BE TREATED WITH SEVERAL UNSPECIFIED BALLOONS, ALL UNSUCCESSFULLY. WHEN A JADE PTA OTW 5 X 150 MM BALLOON WAS ATTEMPTED TO BE USED, IT RUPTURED WHEN IT REACHED ROUGHLY 22-24 ATMOSPHERES. THE RUPTURED COMPONENT CAME ENTIRELY OFF THE SHAFT. THERE WAS A DELAY OF A FEW HOURS WHILE THE PHYSICIAN PLACED STENTS. ADDITIONALLY, A CUT DOWN OF A CLOT IN THE COMMON FEMORAL WAS PERFORMED. THE HYPOTUBE WAS ABLE TO BE REMOVED FROM THE COMMON FEMORAL DURING THIS TIME, HOWEVER, THE RUPTURED COMPONENTS REMAINED IN-VIVO. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COMPONENTS; HOWEVER, THEY WERE DIFFICULT TO BE IDENTIFIED WITH ANGIOGRAPHIC IMAGING AND THEREFORE, STENTS WERE PLACED IN THE AREA WHERE THE BALLOON RUPTURED. THE PHYSICIAN BELIEVED THE STENTS WERE ABLE TO COVER THE RUPTURED COMPONENT. AT THE END OF THE PROCEDURE, IT WAS INDICATED THAT THE FLOW WAS SUFFICIENT AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 21775326 ↗
• MalfunctionMar 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A NON-DILATABLE, HEAVILY CALCIFIED, HEAVILY TORTUOUS SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION WAS ATTEMPTED TO BE TREATED WITH SEVERAL UNSPECIFIED BALLOONS, ALL UNSUCCESSFULLY. WHEN A JADE PTA OTW 5 X 150 MM BALLOON WAS ATTEMPTED TO BE USED, IT RUPTURED WHEN IT REACHED ROUGHLY 22-24 ATMOSPHERES. THE RUPTURED COMPONENT CAME ENTIRELY OFF THE SHAFT. THERE WAS A DELAY OF A FEW HOURS WHILE THE PHYSICIAN PLACED STENTS. ADDITIONALLY, A CUT DOWN OF A CLOT IN THE COMMON FEMORAL WAS PERFORMED. THE HYPOTUBE WAS ABLE TO BE REMOVED FROM THE COMMON FEMORAL DURING THIS TIME, HOWEVER, THE RUPTURED COMPONENTS REMAINED IN-VIVO. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COMPONENTS; HOWEVER, THEY WERE DIFFICULT TO BE IDENTIFIED WITH ANGIOGRAPHIC IMAGING AND THEREFORE, STENTS WERE PLACED IN THE AREA WHERE THE BALLOON RUPTURED. THE PHYSICIAN BELIEVED THE STENTS WERE ABLE TO COVER THE RUPTURED COMPONENT. AT THE END OF THE PROCEDURE, IT WAS INDICATED THAT THE FLOW WAS SUFFICIENT AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS IN STABLE CONDITION. NO CASE IMAGE/CD AND OTHER INFORMATION WAS PROVIDED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21728429 ↗