Jade PTA Balloon Dilatation Catheter 586010022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934955901348), received between Aug 7, 2025 and Aug 15, 2025 — classified as 2 injuries, 1 malfunction.

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.

• MalfunctionAug 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATMOSPHERES (ATM) FOR 2 MINUTES AND THEN DEFLATED. AN INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE THE BALLOON WAS REMOVED FROM THE WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50 MILLIMETERS (MM) IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WERE PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22813616 ↗
• InjuryAug 15, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATMOSPHERES (ATM) FOR 2 MINUTES AND THEN DEFLATED. AN INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE THE BALLOON WAS REMOVED FROM THE WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50 MILLIMETERS (MM) IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WERE PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. THE PATIENT'S STATUS WAS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22813602 ↗
• InjuryAug 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATM FOR 2 MINUTES AND THEN DEFLATED. INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE BALLOON WAS WALKED OF WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50MM IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WAS PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22742963 ↗