Jade PTA Balloon Dilatation Catheter 581524022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06934955900754), received between Jul 11, 2024 and Jul 24, 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.

• InjuryJul 24, 2024Material Separation; Material Separation

  DURING A PERIPHERAL PROCEDURE TO TREAT 99% DIFFUSED STENOSED CALCIFIED LESION ABOUT 2MM-3MM IN DIAMETER IN RIGHT ANTERIOR TIBIAL (AT) ARTERY VIA LEFT COMMON FEMORAL APPROACH WITH A 6 FR 90 CM NON-CSI ABBOTT SHEATH, A 1.5MM X 240 MM JADE BALLOON WAS ADVANCED OVER A GUIDEWIRE. THE BALLOON RUPTURED UPON FIRST INFLATION. UPON REMOVAL OF THE RUPTURED BALLOON, IT WAS NOTICED THAT THE ACTUAL BALLOON HAD SEPARATED OFF OF THE DELIVERY CATHETER AND WAS LEFT IN THE PATIENT'S RIGHT AT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON USING A NON-CSI/ABBOTT SNARE BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE VIA PEDAL AT ACCESS APPROACH TO RETRIEVE THE BALLOON USING A NON-CSI/ABBOTT SNARE, WHICH WAS ALSO UNSUCCESSFUL. ANOTHER 1.5MM X 240MM JADE BALLOON WAS ADVANCED NEXT TO THE SHEARED OFF BALLOON IN THE VESSEL, IN AN ATTEMPT TO INFLATE AND DRAG THE BALLOON BACK OUT OF THE AT, HOWEVER THIS WAS ALSO UNSUCCESSFUL. AFTER SEVERAL FAILED ATTEMPTS TO RETRIEVE THE SHEARED OFF BALLOON, THE PHYSICIAN DECIDED TO LEAVE THE BALLOON IN THE AT. THE AT WAS ORIGINALLY OCCLUDED AT THE BEGINNING OF THE PROCEDURE, AND HENCE LEAVING THE BALLOON IN THE AT DID NOT CAUSE ANY ADDITIONAL DAMAGE AND DID NOT BLOCK FLOW,

  Patient problems: Foreign Body In Patient

  MAUDE report 19820260 ↗
• InjuryJul 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A PERIPHERAL PROCEDURE TO TREAT 99% DIFFUSED STENOSED CALCIFIED LESION ABOUT 2MM-3MM IN DIAMETER IN RIGHT ANTERIOR TIBIAL (AT) ARTERY VIA LEFT COMMON FEMORAL APPROACH WITH A 6 FR 90 CM NON-CSI ABBOTT SHEATH, A 1.5MM X 240 MM JADE BALLOON WAS ADVANCED OVER A GUIDEWIRE. THE BALLOON RUPTURED UPON FIRST INFLATION. UPON REMOVAL OF THE RUPTURED BALLOON, IT WAS NOTICED THAT THE ACTUAL BALLOON HAD SEPARATED OFF OF THE DELIVERY CATHETER AND WAS LEFT IN THE PATIENT'S RIGHT AT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON USING A NON-CSI/ABBOTT SNARE BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE VIA PEDAL AT ACCESS APPROACH TO RETRIEVE THE BALLOON USING A NON-CSI/ABBOTT SNARE, WHICH WAS ALSO UNSUCCESSFUL. ANOTHER 1.5MM X 240MM JADE BALLOON WAS ADVANCED NEXT TO THE SHEARED OFF BALLOON IN THE VESSEL, IN AN ATTEMPT TO INFLATE AND DRAG THE BALLOON BACK OUT OF THE AT, HOWEVER THIS WAS ALSO UNSUCCESSFUL. AFTER SEVERAL FAILED ATTEMPTS TO RETRIEVE THE SHEARED OFF BALLOON, THE PHYSICIAN DECIDED TO LEAVE THE BALLOON IN THE AT. THE AT WAS ORIGINALLY OCCLUDED AT THE BEGINNING OF THE PROCEDURE, AND HENCE LEAVING THE BALLOON IN THE AT DID NOT CAUSE ANY ADDITIONAL DAMAGE AND DID NOT BLOCK FLOW,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19718058 ↗