Jade PTA Balloon Dilatation Catheter 596015022Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 06934955903939), received between Jul 10, 2025 and Nov 24, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Separation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT FOLLOWING LASER ATHERECTOMY, THE JADE BALLOON WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN AN 80MM SEGMENT. THE BALLOON ADVANCED AND INFLATED WITH NO ISSUES, HOWEVER, THE ARTERY COULD NOT OPEN UP UPON INFLATION. SEVERAL ATTEMPTS WERE MADE AND THE SEGMENT DECREASED FROM 80MM TO 40MM, HOWEVER, COULD NOT OPEN FURTHER. DURING TREATMENT, THE BALLOON RUPTURED. WHEN THE BALLOON WAS AT THE 6F SHEATH, THE BALLOON ACCORDIONED AND UPON THE CATHETER REMOVAL, THE BALLOON MEMBRANE REMAINED IN VIVO AT THE EXTERNAL ILIAC/FEMORAL LOCATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO PERFORM SURGERY TO REMOVE THE FRAGMENT. THE COMPONENT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640814 ↗
• InjuryNov 24, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT FOLLOWING LASER ATHERECTOMY, THE JADE BALLOON WAS USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN AN 80MM SEGMENT. THE BALLOON ADVANCED AND INFLATED WITH NO ISSUES, HOWEVER, THE ARTERY COULD NOT OPEN UP UPON INFLATION. SEVERAL ATTEMPTS WERE MADE AND THE SEGMENT DECREASED FROM 80MM TO 40MM, HOWEVER, COULD NOT OPEN FURTHER. DURING TREATMENT, THE BALLOON RUPTURED. WHEN THE BALLOON WAS AT THE 6F SHEATH, THE BALLOON ACCORDIONED AND UPON THE CATHETER REMOVAL, THE BALLOON MEMBRANE REMAINED IN VIVO AT THE EXTERNAL ILIAC/FEMORAL LOCATION. THE PATIENT WAS TRANSFERRED TO A HOSPITAL TO PERFORM SURGERY TO REMOVE THE FRAGMENT. THE COMPONENT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640487 ↗
• InjuryAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON WAS PLACED IN PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS INFLATED TO 12 ATMOSPHERES. THE BALLOON RUPTURED. DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON HAD BROKEN IN-VIVO AND BECAME COMPLETELY DETACHED. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER WIRE THROUGH THE EXISTING 6F NON-ABBOTT CONTRALATERAL SHEATH, BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO PUNCTURE THE SFA ANTEGRADE DIRECTLY BELOW THE BROKEN BALLOON. A STENT WAS PLACED WITH DIFFICULTY TO ADHERE THE BALLOON AGAINST THE WALL. THERE WAS DELAY IN THE TREATMENT AS IT ADDED 75 TO 90 MINUTES TO THE PROCEDURE WITH TWO ADDITIONAL PUNCTURES THAT WERE REQUIRED. THE PATIENT WAS DISCHARGED AFTER BEDREST.

  Patient problems: Foreign Body In Patient

  MAUDE report 22724103 ↗
• InjuryAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON WAS PLACED IN PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS INFLATED TO 12 ATMOSPHERES. THE BALLOON RUPTURED. DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON HAD BROKEN IN-VIVO AND BECAME COMPLETELY DETACHED. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER WIRE THROUGH THE EXISTING 6F NON-ABBOTT CONTRALATERAL SHEATH, BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO PUNCTURE THE SFA ANTEGRADE DIRECTLY BELOW THE BROKEN BALLOON. A STENT WAS PLACED WITH DIFFICULTY TO ADHERE THE BALLOON AGAINST THE WALL. THERE WAS DELAY IN THE TREATMENT AS IT ADDED 75 TO 90 MINUTES TO THE PROCEDURE WITH TWO ADDITIONAL PUNCTURES THAT WERE REQUIRED. THE PATIENT WAS DISCHARGED AFTER BEDREST.

  Patient problems: Foreign Body In Patient

  MAUDE report 22724080 ↗
• InjuryJul 10, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING PROCEDURE, A JADE BALLOON WAS PLACED IN PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS INFLATED TO 12 ATMOSPHERES. THE BALLOON RUPTURED. DURING REMOVAL, IT WAS NOTICED THAT THE BALLOON HAD BROKEN IN-VIVO AND BECAME COMPLETELY DETACHED. AN ATTEMPT WAS MADE TO ADVANCE ANOTHER WIRE THROUGH THE EXISTING 6F NON-ABBOTT CONTRALATERAL SHEATH, BUT WAS UNSUCCESSFUL. THE PHYSICIAN HAD TO PUNCTURE THE SFA ANTEGRADE DIRECTLY BELOW THE BROKEN BALLOON. A STENT WAS PLACED WITH DIFFICULTY TO ADHERE THE BALLOON AGAINST THE WALL. THERE WAS DELAY IN THE TREATMENT AS IT ADDED 75 TO 90 MINUTES TO THE PROCEDURE WITH TWO ADDITIONAL PUNCTURES THAT WERE REQUIRED. THE PATIENT WAS DISCHARGED AFTER BEDREST.

  Patient problems: Foreign Body In Patient

  MAUDE report 22473161 ↗