Jade PTA Balloon Dilatation Catheter 597010022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 06934955904028), received between Jun 26, 2025 and Jul 11, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT NON-ABBOTT LASER WAS USED FOR ATHERECTOMY TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, A STENT WAS PLACED, POST STENT DILATION WAS PERFORMED WITH A JADE .018 OTW 7.00MMX100MM 150 CM BALLOON. THE BALLOON WAS DILATED UP TO BURST PRESSURE OF 16 ATMOSPHERES (ATM), AND THE BALLOON BURST. THE PHYSICIAN WENT DOUBLE NEGATIVE ON THE BALLOON, PULLED THE BALLOON BACK TO TAKE OUT OF BODY. WHEN BALLOON WAS REMOVED FROM THE BODY, IT WAS EVIDENT ON THE CATHETER THAT ONLY A PIECE OF THE BALLOON WAS STILL ATTACHED. AFTER FLUOROSCOPY, REMANENT OF THE BALLOON APPEARED STILL IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON WITHIN ANOTHER CATHETER AND WAS UNSUCCESSFUL. THE PATIENT LEFT FOR SURGERY. A CUTDOWN WAS PERFORMED TO REMOVE THE BALLOON FRAGMENTS. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477545 ↗
• InjuryJul 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT NON-ABBOTT LASER WAS USED FOR ATHERECTOMY TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, A STENT WAS PLACED, POST STENT DILATION WAS PERFORMED WITH A JADE .018 OTW 7.00MMX100MM 150 CM BALLOON. THE BALLOON WAS DILATED UP TO BURST PRESSURE OF 16 ATMOSPHERES (ATM), AND THE BALLOON BURST. THE PHYSICIAN WENT DOUBLE NEGATIVE ON THE BALLOON, PULLED THE BALLOON BACK TO TAKE OUT OF BODY. WHEN BALLOON WAS REMOVED FROM THE BODY, IT WAS EVIDENT ON THE CATHETER THAT ONLY A PIECE OF THE BALLOON WAS STILL ATTACHED. AFTER FLUOROSCOPY, REMANENT OF THE BALLOON APPEARED STILL IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON WITHIN ANOTHER CATHETER AND WAS UNSUCCESSFUL. THE PATIENT LEFT FOR SURGERY. A CUTDOWN WAS PERFORMED TO REMOVE THE BALLOON FRAGMENTS. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477072 ↗
• InjuryJun 26, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT NON-ABBOTT LASER WAS USED FOR ATHERECTOMY TO TREAT A DISEASED SUPERFICIAL FEMORAL ARTERY (SFA). AFTER ATHERECTOMY, A STENT WAS PLACED, POST STENT DILATION WAS PERFORMED WITH A JADE .018 OTW 7.00MMX100MM 150 CM BALLOON. THE BALLOON WAS DILATED UP TO BURST PRESSURE OF 16 ATMOSPHERES (ATM), AND THE BALLOON BURST. THE PHYSICIAN WENT DOUBLE NEGATIVE ON THE BALLOON, PULLED THE BALLOON BACK TO TAKE OUT OF BODY. WHEN BALLOON WAS REMOVED FROM THE BODY, IT WAS EVIDENT ON THE CATHETER THAT ONLY A PIECE OF THE BALLOON WAS STILL ATTACHED. AFTER FLUOROSCOPY, REMANENT OF THE BALLOON APPEARED STILL IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BALLOON WITHIN ANOTHER CATHETER AND WAS UNSUCCESSFUL. THE PATIENT LEFT FOR SURGERY. A CUTDOWN WAS PERFORMED TO REMOVE THE BALLOON FRAGMENTS. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22338750 ↗