Jade PTA Balloon Dilatation Catheter 582524032Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955901621), received between Jul 25, 2024 and Aug 5, 2024 — 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.

• InjuryAug 5, 2024Material Separation; Material Separation

  DURING TREATMENT OF AN 80%-90% MIXED CALCIFIED PLAQUE/LESION WHICH WAS APPROXIMATELY 2.0 MM- 2.5 MM IN LENGTH, IN THE DISTAL POSTERIOR TIBIAL ARTERY, THE JADE BALLOON SEPARATED FROM THE CATHETER ON EXITING THE SHEATH DURING THE PROCEDURE. THE BALLOON WAS INITIALLY INFLATED AT LESION SITE. THERE WAS DIFFICULTY TO REMOVE THE ORBITAL ATHERECTOMY DEVICE (OAD) AFTER BALLOON DEFLATION. HOWEVER, THE BALLOON WAS PULLED AND EVENTUALLY REMOVED. AFTER PHYSICAL INSPECTION AND RESULTS FROM ANGIOGRAPHY SHOWED A PART OF BALLOON AT THE SITE OF INFLATION AND THIS PART OF THE BALLOON WAS LEFT IN THE LEG. BACKGROUND: RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ON JULY 25, 2024: 1. WHEN DID THE PROBLEM OCCUR? (DURING SET-UP, PROCEDURE, OR PERFORMANCE TESTING) - DURING PROCEDURE. 2. COULD YOU PLEASE PROVIDE VESSEL AND LESION DETAILS? (VESSEL, LESION LOCATION, % STENOSIS, LEVEL OF CALCIFICATION, DIAMETER, ETC.) - DISTAL PT. 80%-90% MIXED CALCIFIED/PLAQUE LESION. APPROX. 2.0MM-2.5MM DIAMETER. 3. WAS THE BALLOON INFLATED DURING THE PROCEDURE? - BALLOON WAS INFLATED AT LESION SITE. 4. DID THE BALLOON REMAIN INTACT AND COMPLETELY REMOVED FROM THE BODY? - AFTER BALLOON DEFLATION, DEVICE WAS DIFFICULT TO RE

  Patient problems: Foreign Body In Patient

  MAUDE report 19903963 ↗
• InjuryJul 25, 2024Material Separation; Material Separation

  DURING TREATMENT OF AN 80%-90% MIXED CALCIFIED PLAQUE/LESION WHICH WAS APPROXIMATELY 2.0 MM- 2.5 MM IN LENGTH, IN THE DISTAL POSTERIOR TIBIAL ARTERY, THE JADE BALLOON SEPARATED FROM THE CATHETER ON EXITING THE SHEATH DURING THE PROCEDURE. THE BALLOON WAS INITIALLY INFLATED AT LESION SITE. THERE WAS DIFFICULTY TO REMOVE THE ORBITAL ATHERECTOMY DEVICE (OAD) AFTER BALLOON DEFLATION. HOWEVER, THE BALLOON WAS PULLED AND EVENTUALLY REMOVED. AFTER PHYSICAL INSPECTION AND RESULTS FROM ANGIOGRAPHY SHOWED A PART OF BALLOON AT THE SITE OF INFLATION AND THIS PART OF THE BALLOON WAS LEFT IN THE LEG.

  Patient problems: Foreign Body In Patient

  MAUDE report 19829743 ↗