Advance G52340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002523408), received between Jul 28, 2017 and Jul 15, 2022 — classified as 5 malfunctions.

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

• MalfunctionJul 15, 2022Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AT NINE ATMOSPHERES AND A PINHOLE LEAK WAS NOTED. ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT THE SEVERELY STENOSED AND SEVERELY CALCIFIED LESION IN THE MIDDLE OF THE LEFT FEMORAL ARTERY. ANOTHER MANUFACTURER'S SHEATH AND WIRE GUIDE WERE USED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME, AT WHICH POINT THE BALLOON RUPTURED. THE BALLOON WAS REMOVED BY ITSELF AND A LARGER COOK ADVANCE BALLOON WAS USED TO DILATE THE TARGET SITE. THE STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026483 ↗
• MalfunctionSep 14, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN ENDOVASCULAR THERAPY PROCEDURE VIA FEMORAL ACCESS, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. REPORTEDLY, THE USER INFLATED THE BALLOON WITH "AIR PRESSURE WITHIN THE INSTRUCTION IN THE PATIENT'S BODY", HOWEVER, THE BALLOON COULD NOT BE INFLATED. UPON REMOVAL OF THE COMPLAINT DEVICE, THE USER FOUND THAT THE BALLOON HAD RUPTURED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10529092 ↗
• MalfunctionJun 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED IN A PATIENT'S ANATOMY DURING ENDOVASCULAR THERAPY. THERE WAS NO ANGULATION OR CALCIFICATION OF THE VESSEL. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE LEFT FEMORAL ARTERY (FA) TO THE LEFT COMMON ILIAC ARTERY (CIA) FOR BALLOON POST-DILATION AFTER PLACING ANOTHER MANUFACTURER'S STENTS IN THE LEFT CIA. THE COMPLAINT DEVICE RUPTURED WHEN THE PRESSURE WAS RAISED TO APPROXIMATELY SIX ATMOSPHERES (ATM). ANOTHER BALLOON CATHETER OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. CONTRAST USED: OYPALOMIN IN A 1:2 MIX WITH NORMAL SALINE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7630577 ↗
• MalfunctionOct 10, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A FISTULA CASE IN THE ARM, IT WAS VERY STENOTIC. THERE WAS NO VESSEL CALCIFICATION, BUT THERE WAS A PREVIOUSLY PLACED STENT IN THE VESSEL NEAR THE AREA WHERE THE BALLOON WAS BEING PLACED. IT WAS REPORTED THAT THE BALLOON RUPTURED UPON INFLATION WITH NOMINAL PRESSURE. THEY USED 50% SALINE AND 50% CONTRAST. ANOTHER MANUFACTURER'S BALLOON WAS OPENED AND USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937559 ↗
• MalfunctionJul 28, 2017Material Rupture

  THE USER GAINED ACCESS THROUGH THE RIGHT FEMORAL ARTERY TO TREAT A TOTAL OCCLUDED LESION OF SUPERFICIAL FEMORAL ARTERY BY IPSILATERAL APPROACH. SEVERE CALCIFICATION WAS NOTED IN THE PATIENT. THE GUIDE WIRE WAS PASSED THROUGH THE LESION. THEN THE USER MADE AN UNSUCCESSFUL ATTEMPTED TO PASS THE BALLOON CATHETER THROUGH THE LESION. TO INCREASE THE SUPPORT FOR THE BALLOON, THE PHYSICIAN SWITCHED GUIDE WIRES TWICE. WHILE INFLATING THE BALLOON CATHETER TO NOMINAL PRESSURE THE BALLOON RUPTURED. THE PHYSICIAN NOTED A LONGITUDINAL RUPTURE. ANOTHER MANUFACTURES' BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750459 ↗