Jade PTA Balloon Dilatation Catheter 586008022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955901331), received between Jul 8, 2026 and Jul 8, 2026 — classified as 2 injuries.

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

• InjuryJul 8, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN AN UNSPECIFIED RIGHT LOWER EXTREMITY ARTERY. DURING THE PROCEDURE VIA COMMON FEMORAL ARTERY ACCESS THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 7/7/2026: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, MILD TORTUOUS, 90% STENOSED LESION IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA COMMON FEMORAL ARTERY ACCESS. DURING THE PROCEDURE THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED UPON REMOVAL OF THE BALLOON FROM THE SHEATH AND CAME OFF INSIDE THE DISTAL SFA STENT. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP BUT WAS NOT COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED AS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. Q1. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PLEASE PROVIDE REASON IF UNAVAILABLE (HOSPITAL POLICY, ETC.) A1. RIGHT SFA, DISTAL RIGHT SFA HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSIS. Q2. IS THERE ANY INDICATION AS T

  Patient problems: Foreign Body In Patient

  MAUDE report 25757583 ↗
• InjuryJul 8, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT LESION IN AN UNSPECIFIED RIGHT LOWER EXTREMITY ARTERY. DURING THE PROCEDURE VIA COMMON FEMORAL ARTERY ACCESS THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026: "IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, MILD TORTUOUS, 90% STENOSED LESION IN RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA COMMON FEMORAL ARTERY ACCESS. DURING THE PROCEDURE THE TIP OF THE 6.0MM X 80MM JADE 14 PTA OTW BALLOON FRACTURED UPON REMOVAL OF THE BALLOON FROM THE SHEATH AND CAME OFF INSIDE THE DISTAL SFA STENT. SURGICAL CUT-DOWN WAS PERFORMED TO REMOVE THE BALLOON TIP BUT WAS NOT COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED AS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED. Q1. ANATOMICAL INFORMATION? (VESSEL / LOCATION / TORTUOSITY / CALCIFICATION / STENOSIS % / ETC.) PLEASE PROVIDE REASON IF UNAVAILABLE (HOSPITAL POLICY, ETC.) A1. RIGHT SFA, DISTAL RIGHT SFA HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSIS Q2. IS THERE ANY INDICATION A

  Patient problems: Foreign Body In Patient

  MAUDE report 25757580 ↗