Advance G52251Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002522517), received between Mar 15, 2017 and Dec 12, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2017Material Rupture; Material Rupture

  DURING STENT PLACEMENT TO REPAIR A PATIENT'S TOTAL CHRONIC OCCLUSION LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA), ACCESS WAS GAINED VIA THE FEMORAL ARTERY, AND SEVERE CALCIFICATION WAS NOTED AT THE LESION SITE BETWEEN THE ORIGIN OF THE SFA AND THE POPLITEAL ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE ANOTHER MANUFACTURER'S 0.014 INCH DIAMETER WIRE GUIDE WITHIN THE TRUE LUMEN OF THE ARTERY, BUT ENCOUNTERED DIFFICULTLY DUE TO THE PATIENT'S ARTERIAL CALCIFICATION. THE PHYSICIAN THEN SWITCHED THE 0.014 WIRE GUIDE WITH ANOTHER MANUFACTURER'S 0.035 INCH DIAMETER WIRE GUIDE AND A COOK MEDICAL CXI SUPPORT CATHETER TO PERFORM KNUCKLE WIRE TECHNIQUE. THE 0.035 WIRE GUIDE AND CXI CATHETER BECAME CAUGHT IN THE MIDDLE OF THE CALCIFIED LESION DURING ADVANCEMENT, AND THE CXI CATHETER WAS KINKED NEAR THE TIP. ANOTHER CXI CATHETER WAS UTILIZED TO SUCCESSFULLY PASS THROUGH THE CALCIFIED SFA LESION. AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS THEN ADVANCED TO THE LESION TO PERFORM COMPRESSION, AND RUPTURED DURING INFLATION PRIOR TO REACHING NOMINAL PRESSURE. A 0.014 INCH DIAMETER WIRE GUIDE WAS ADVANCED TO THE SFA LESION TO PERFORM PRE-BALLOONING, AND THE STENT WAS REPORTED TO BE SUCCESSFULLY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7109528 ↗
• MalfunctionJul 26, 2017Material Rupture

  IT WAS REPORTED AFTER BEING USED FOR PRE-DILATION, THE BALLOON CATHETER WAS REINSERTED. SUBSEQUENTLY, THE BALLOON RUPTURED WHEN INFLATED AT RATED BURST PRESSURE. AS A RESULT, ANOTHER MANUFACTURER'S BALLOON CATHETER WAS THEN USED FOR PRE-DILATION. AFTER THIS, THE PTX6 X 40 WAS SUCCESSFULLY PLACED. FOCAL CALCIFIED CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY WAS NOTED THE DEVICE WAS INSERTED BY CONTRALATERAL APPROACH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6745407 ↗
• MalfunctionJul 19, 2017Burst Container or Vessel

  DURING A PROCEDURE, THE BALLOON BURST AT 8ATM. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT'S BODY, AND NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725375 ↗
• MalfunctionJul 19, 2017Burst Container or Vessel

  DURING A PROCEDURE, THE BALLOON BURST AT 8ATM. NO PART OF THE DEVICE WAS LEFT IN THE PATIENT'S BODY, AND NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6725371 ↗
• MalfunctionJul 17, 2017Material Rupture

  IT WAS REPORTED DURING THE PROCEDURE, THE DEVICE WAS ADVANCED CONTRALATERALLY TO THE LESION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. AFTER THE GUIDING SHEATH WAS INSERTED, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON CATHETER; HOWEVER, IT RUPTURED (PINHOLE). SINCE THE BALLOON WAS CAUGHT WHILE ADVANCING, A DIFFERENT SIZED BALLOON WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. IT WAS NOTED THAT DIFFUSE CALCIFIED LESION WAS OBSERVED. ANOTHER MANUFACTURER'S BALLOON CATHETER WAS USED PRIOR TO THE COMPLAINT DEVICE AND DID NOT RUPTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719789 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel

  DURING A LEFT LEG ANGIO PROCEDURE, THE BALLOON BURST IN THE PATIENT'S POPLITEAL ARTERY AT ABOUT 8 ATM. PER THE REPORTER, THE PATIENT'S VESSEL WAS SLIGHTLY CALCIFIED AND THEY REMOVED THE BALLOON AS THEY NORMALLY WOULD. NO EXTRA TOOLS WERE NEEDED AND NOTHING WAS LEFT BEHIND IN THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PHYSICIAN USED ANOTHER BALLOON TO FINISH THE INTERVENTION.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 6714896 ↗
• MalfunctionMar 15, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO TREAT A SEVERELY CALCIFIED LESION OF THE ETERNAL ILIAC ARTERY FROM THE BRACHIAL ARTERY HOWEVER, THE BALLOON RUPTURED. ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THAT THERE IS A POSSIBILITY THAT THE RUPTURE WAS CAUSED BY THE DEVICE STICKING TO THE CALCIFIED LESION. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6407874 ↗