Jade PTA Balloon Dilatation Catheter 596024032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955904936), received between Apr 25, 2024 and May 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryMay 13, 2024Material Separation; Material Separation

  THE JADE OTW .018" 200CM (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) PTA BALLOON WAS USED FOR TREATMENT OF 99% STENOSED, HEAVILY CALCIFIED, IN-STENT RESTENOSIS (ISR) LESION IN SUPERFICIAL FEMORAL ARTERY (SFA) VIA RADIAL ACCESS 6FR GUIDING SHEATH WAS IN USE. THE NON-CSI/NON-ABBOTT ATHERECTOMY CATHETER HAD DIFFICULTY TRACKING ON THE VIPERWIRE ADVANCE GUIDE WIRE WITH FLEX TIP BUT ATHERECTOMY WAS ABLE TO BE PERFORMED ON THE ISR LESION. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE VIPERWIRE. THE VIPERWIRE AND NON-CSI/NON-ABBOTT ATHERECTOMY CATHETER WERE REMOVED. THE JADE OTW BALLOON WAS ADVANCED OVER THE NON-CSI/NON- ABBOTT WORKHORSE FRONTLINE GUIDE WIRE INTO THE ISR AND INFLATED AT SIXTEEN ATMOSPHERES (ATM). THE NOMINAL PRESSURE IS FOURTEEN ATM AND THE BURSTING PRESSURE IS EIGHTEEN ATM. DURING INFLATION, THE PATIENT BENT THEIR LEG THAT WAS BEING TREATED. THE BALLOON BURST. THE BURST BALLOON HAD THREE COMPONENTS. THE MAJOR PART WAS ATTACHED TO THE CATHETER AND WAS REMOVED ALONG WITH THE SECOND PART. CINE ANGIOGRAPHIC IMAGING AND FLUOROSCOPY REVEALED THE THIRD COMPONENT REMAINED IN THE RIGHT BRACHIAL ARTERY. MECHANICAL ASPIRATION WAS ATTEMPTED VIA RADIAL ACCESS TO SNARE THE FRACTURED C

  Patient problems: Foreign Body In Patient

  MAUDE report 19299306 ↗
• InjuryApr 25, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE JADE OTW .018" 200CM PTA BALLOON WAS USED FOR TREATMENT OF 99% STENOSED, HEAVILY CALCIFIED, IN-STENT RESTENOSIS (ISR) LESION IN SUPERFICIAL FEMORAL ARTERY (SFA) VIA RADIAL ACCESS. 6FR TERUMO GUIDING SHEATH WAS IN USE. THE NON-CSI/NON-ABBOTT ATHERECTOMY CATHETER (AURYON) HAD DIFFICULTY TRACKING ON THE VIPERWIRE ADVANCE GUIDE WIRE WITH FLEX TIP BUT ATHERECTOMY WAS ABLE TO BE PERFORMED ON THE ISR LESION. THERE WAS NO ALLEGATION OF MALFUNCTION AGAINST THE VIPERWIRE. THE VIPERWIRE AND NON-CSI/NON-ABBOTT ATHERECTOMY CATHETER WERE REMOVED. THE JADE OTW BALLOON WAS ADVANCED OVER THE ASAHI MINAMO WORKHORSE FRONTLINE GUIDE WIRE INTO THE ISR AND INFLATED AT SIXTEEN ATMOSPHERES (ATM). THE NOMINAL PRESSURE IS FOURTEEN ATM AND THE BURSTING PRESSURE IS EIGHTEEN ATM. DURING INFLATION, THE PATIENT BENT HIS LEG THAT WAS BEING TREATED. THE BALLOON BURST. THE BURST BALLOON HAD THREE COMPONENTS. THE MAJOR PART WAS ATTACHED TO THE CATHETER AND WAS REMOVED ALONG WITH THE SECOND PART. CINE ANGIOGRAPHIC IMAGING AND FLUOROSCOPY REVEALED THE THIRD COMPONENT REMAINED IN THE RIGHT BRACHIAL ARTERY. MECHANICAL ASPIRATION WAS ATTEMPTED VIA RADIAL ACCESS TO SNARE THE FRACTURED COMPONENT BUT FAILED. MECHANICAL

  Patient problems: Foreign Body In Patient

  MAUDE report 19178419 ↗