Advance G52345Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10827002523453), received between Feb 9, 2017 and Jun 26, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING PRE-DILATION, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE LESION WAS LOCATED AT THE CHRONICALLY OCCLUDED (100%) SUPERFICIAL FEMORAL ARTERY. THE VESSEL HAD "SERIOUS" CALCIFICATION. ANOTHER MANUFACTURER'S SHEATH AND UNSPECIFIED INFLATION DEVICE WERE USED DURING THE PROCEDURE. THE BALLOON WAS INFLATED ONE TIME, AND A PINHOLE WAS NOTED BEFORE THE BALLOON REACHED NOMINAL PRESSURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. JUST THE BALLOON WAS REMOVED, AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619599 ↗
• MalfunctionSep 12, 2023Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728310 ↗
• MalfunctionApr 11, 2022Material Rupture; Material Rupture

  AS REPORTED, A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED AND THE BALLOON RUPTURED. APPROACH WAS GAINED FROM THE FEMORAL ARTERY, AND THE REPORTED DEVICE WAS USED FOR A CALCIFIED LESION IN THE COMMON FEMORAL ARTERY. THE BALLOON RUPTURED DURING THE FIRST INFLATION OF THE DEVICE, AND THEN THE BALLOON WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE INSTEAD. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074163 ↗
• MalfunctionFeb 1, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING A CALCIFIED ILIAC LESION, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS INSERTED VIA THE FEMORAL ARTERY AND RUPTURED UPON THE FIRST INFLATION. ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. NO ADVERSE EVENTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419142 ↗
• MalfunctionAug 19, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED 18OCT2021. PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. PROCEDURE WAS COMPLETED WITH "GOOD RESULTS". NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341724 ↗
• MalfunctionMay 26, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11884339 ↗
• MalfunctionMar 19, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526038 ↗
• MalfunctionJul 31, 2020Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10352946 ↗
• MalfunctionJul 21, 2020Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 07AUG2020. THE COMPLAINT DEVICE WAS INFLATED TWICE, USING A 50:50 RATIO OF CONTRAST TO SALINE, FOR "A FEW SECONDS". THE BALLOON WAS PREPPED AS USUAL. CALCIFICATION AND ANGULATION WERE NOT NOTED. AN UNKNOWN PRESSURE DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302674 ↗
• MalfunctionOct 20, 2017Material Rupture; Material Rupture

  TWO ADVANCE 35 LP LOW PROFILE BALLOON CATHETERS WERE USED IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED THAT THE FIRST BALLOON (1820334-2017-03626) BURST AT THE INTERSECTION, BUT WAS STILL ABLE TO BE PULLED THROUGH THE INTRODUCER, AND REMOVED WITHOUT DIFFICULTY. A SECOND BALLOON (1820334-2017-03627) RIPPED APART INTO TWO PIECES AND WAS RETRIEVED WITH A SNARE. ACCORDING TO THE INITIAL REPORTER, 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, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6966784 ↗
• MalfunctionSep 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HAIR WAS FOUND IN THE STERILE PACKAGING OF AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6894968 ↗
• MalfunctionMay 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A LEG PROCEDURE USING THE ADVANCE 35 LOW PROFILE BALLOON CATHETER, THE BALLOON GOT STUCK INSIDE THE STENT AND BURST RADIALLY. THE PATIENT WAS NOT INJURED HOWEVER THE PROCEDURE WAS PROLONGED MORE THAN 45 MINUTES. AS REPORTED ON THE COMPLAINT FORM, THE STENT WAS NOT FULLY DEPLOYED AND THE SPECIALIST WANTED TO DILATE IT USING A BALLOON. THE BALLOON BURST WHILE INFLATING AND GOT STUCK INSIDE OF THE STENT. IT WAS ALSO CLARIFIED VIA EMAIL THAT BY RADIALLY, THEY ACTUALLY MEANT THAT THE BALLOON RUPTURED CIRCUMFERENTIALLY. 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 6594115 ↗
• InjuryFeb 9, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT UNDERWENT EVAR FOR (B)(4) WITH GORE'S DEVICE (EXLUDER). THE COMPLAINT WIRE GUIDE PERFORATED TO THE PATIENTS' VESSEL, THEREFORE THE PROCEDURE WAS CONVERTED TO OPEN SURGERY FOR AORTIC RUPTURE. ADDITIONAL INFORMATION RECEIVED 09FEB2015. ON (B)(6) 2015 A (B)(6) MALE PATIENT UNDERWENT EVAR FROM LEFT, THE PATIENT ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS PERFORMED AS LABELED. THE PHYSICIAN ADVANCED THE WIRE GUIDE (RADIFOCUS/TERUMO) ASCENDING DIRECTION FOLLOWED BY DELIVERING THE PIGTAIL, THEN REPLACED THE WIRE GUIDE WITH THE COMPLAINT DEVICE AS USUAL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE PIGTAIL WITHOUT FLUOROSCOPIC CONTROL, HE NOTICED THE COMPLAINT DEVICE CREATED THE LOOP AT THE ABDOMINAL REGION OF THE PATIENT. THEREFORE HE WAS TRYING TO RESOLVE THE LOOP OF COMPLAINT DEVICE BY PULLING IT, HOWEVER THE COMPLAINT DEVICE GOT STACKED BETWEEN CIA AND EIA LESION THAT PUT AN EXTRA LOAD ON THE VESSEL, THEN THE VESSEL RAPTURED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. ADDITIONAL INFORMATION RECEIVED 18FEB2015. PUNCTURE SITE WAS LEFT, NOT RIGHT AS STATED AT FIRST REPORT. THE COMPLAINT DEVICE GOT

  Patient problems: Perforation of Vessels; Rupture

  MAUDE report 6313394 ↗