Advance G52279Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002522791), received between Aug 9, 2016 and Sep 6, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Break; Material Rupture; Break; Material Rupture

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE INVOLVING A PATIENT WITH STENOSIS OF THE ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED, AND THE BALLOON AND CATHETER TIP SEPARATED. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME FOR TWO MINUTES, WITHIN AN EIGHTY-PERCENT OCCLUDED LESION, AT WHICH POINT THE BALLOON RUPTURED LONGITUDINALLY AT SIX ATMOSPHERES. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT PRIOR TO RUPTURING. THE ANATOMY WAS REPORTEDLY NOT TORTUOUS OR CALCIFIED. THE BALLOON CATHETER WAS UNABLE TO BE REMOVED THROUGH A COOK 6-FRENCH FLEXOR SHEATH, DESPITE MULTIPLE ATTEMPTS TO REMOVE THE BALLOON CATHETER. NEGATIVE PRESSURE WAS NOT MAINTAINED DURING ATTEMPTED REMOVAL, AND A COUNTERCLOCKWISE ROTATION OF THE CATHETER WAS NOT CONDUCTED. AFTER THE BALLOON AND CATHETER SEPARATED, AN INCISION WAS MADE IN THE POPLITEAL ARTERY, AND AN UNSPECIFIED GOOSENECK SNARE WAS USED TO REMOVE THE FRAGMENT, ENDING THE PROCEDURE. NO PART OF THE DEVICE REMAINS IN THE PATIENT. THE PROCEDURE WAS PROLONGED, AND THE SURGICAL COST INCREASED. THE USER REPORTED "INCREASED TRAUMA DUE TO THE

  Patient problems: Foreign Body In Patient

  MAUDE report 17691944 ↗
• InjuryNov 24, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 12867955 ↗
• MalfunctionApr 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A CROSSOVER OF THE HEAVILY CALCIFIED COMMON ILIAC ARTERY PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST. NO SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. 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 7446979 ↗
• MalfunctionJul 27, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED DURING A PROCEDURE WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT THE RUPTURE OCCURRED AT NOMINAL PRESSURE, AND THE DIRECTION OF THE RUPTURE IS UNKNOWN AT THIS POINT IN TIME. NO ADVERSE EVENT HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746853 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO TREAT SUBCLAVIAN STENOSIS. TWO BALLOONS WERE CATCHING ON THE STENT STRUTS AND WOULD NOT CROSS. A THIRD BALLOON WAS USED AND RUPTURED AT 7 ATM, WHICH IS UNDER BURST RATE CAPTURED IN THIS MEDWATCH WITH MANUFACTURER REPORT NUMBER 1820334-2017-01795. THE LESION WAS BOTH TORTUOUS AND CALCIFIED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731449 ↗
• MalfunctionJul 17, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO 8 ATM AND IT RUPTURED IN THE COMMON FEMORAL ARTERY. THE VESSEL WAS "LIGHTLY" CALCIFIED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6718759 ↗
• MalfunctionJul 17, 2017Material Rupture

  IT WAS REPORTED DURING THE PROCEDURE, THE BALLOON RUPTURED (LONGITUDINALLY) DUE TO THE PATIENT'S ANATOMY. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716843 ↗
• InjuryJul 12, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT DURING AN AORTIC ILIAC BIFURCATION PROCEDURE USING AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RIPPED. THE PATIENT'S ANATOMY WAS SEVERELY CALCIFIED. THE PHYSICIAN WENT UP WITH THE BALLOON AND THE BALLOON RIPPED IN HALF WHILE COMING BACK DOWN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PARTS OF THE CATHETER BUT NOT THE BALLOON. A STENT WAS PLACED TO COVER THE BALLOON MATERIAL THAT COULD NOT BE RETRIEVED. PER THE PHYSICIAN, EVERYTHING LOOKED GOOD AFTER THE PROCEDURE AND AS OF THE NEXT MORNING THE PATIENT WAS DOING REALLY WELL. THE INFLATION PRESSURE WAS REQUESTED BUT NOT YET PROVIDED. THE TYPE OF CONTRAST THAT WAS USED WAS ISOVIEW AND THE MIX OF CONTRAST TO SALINE WAS A 50/50 RATIO. THE PATIENT'S LESION WAS LOCATED IN THE RIGHT ILIAC WITH SOME ANGULATION. VESSEL CALCIFICATION WAS SEVERE. ADDITIONALLY, IT WAS REPORTED THAT THE BALLOON DID NOT BURST BUT INSTEAD, IT RIPPED CIRCUMFERENTIALLY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO REPORTS OF ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6707359 ↗
• MalfunctionAug 9, 2016Material Rupture; Material Rupture

  IT WAS REPORTED A LOW PROFILE BALLOON CATHETER WAS BEING USED FOR TREATMENT OF CTO (6CM) IN A TORTUOUS AND SEVERELY CALCIFIED RIGHT EXTERNAL ILIAC ARTERY (EIA) BY CONTRALATERAL APPROACH FROM THE LEFT COMMON FEMORAL ARTERY (CFA). INFORMATION PROVIDED BY THE REPRESENTATIVE INDICATED THAT THE DIRECTION CANNOT BE CONFIRMED. THE BALLOON WAS INFLATED AFTER PASSING THROUGH THE LESION, BUT IT RUPTURED APPROXIMATELY AT THE UNIT OF PRESSURE OF 8 ATM. ANOTHER BALLOON WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THE PHYSICIAN STATED THE "EVENT IS LIKELY TO HAVE BEEN CAUSED BY CONDITION OF THE LESION." THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5856043 ↗