Advance G52354Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002523545), received between Mar 16, 2017 and Oct 20, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED UPON THE FIRST INFLATION ATTEMPT WITHIN A HIGHLY CALCIFIED LESION IN THE ILIAC ARTERY. AN UNKNOWN INFLATION DEVICE WAS USED, AS WELL AS ANOTHER MANUFACTURER'S 6 FRENCH CATHETER. THE BALLOON CATHETER WAS REMOVED BY ITSELF, AND ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638639 ↗
• MalfunctionJul 19, 2022Material Rupture; Material Rupture

  AS REPORTED, A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS INSERTED VIA FEMORAL ACCESS TO TREAT LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS CALCIFIED. THE BALLOON WAS INFLATED ONCE FOR AN UNKNOWN DURATION USING AN INFLATION DEVICE BEFORE RUPTURING. THE BALLOON WAS REMOVED FROM THE PATIENT, AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058387 ↗
• MalfunctionJul 29, 2021Material 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 12244918 ↗
• MalfunctionFeb 25, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING AN ENDOSCOPIC THIRD VENTRICULOSTOMY USING A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED. THE BALLOON WAS INFLATED IN A SEVERELY CALCIFIED ILIAC ARTERY LESION. THE BALLOON HAD ONLY BEEN INFLATED ONCE PRIOR TO THE RUPTURE. A DIFFERENT MANUFACTURER'S BALLOON WAS USED TO COMPLETE THE PROCEDURE INSTEAD. NO ADVERSE EFFECTS WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11379067 ↗
• MalfunctionOct 20, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706432 ↗
• MalfunctionMar 16, 2017Material Rupture; Material Rupture

  IT WAS REPORTED, DURING AN UNSPECIFIED PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST AT 2 ATM (29.3919 PSI). NO PORTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT. THERE WERE NO ADDITIONAL PROCEDURES NECESSARY AFTER THE BALLOON BROKE. THERE WAS NO ADVERSE EVENT. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6411385 ↗