Advance G34373Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002343730), received between Sep 18, 2018 and Mar 25, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2020Deflation Problem; Deflation Problem

  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 9877716 ↗
• InjuryFeb 11, 2019Material 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 Code Available

  MAUDE report 8326576 ↗
• InjurySep 18, 2018Material Rupture; Material Rupture

  AN (B)(6) FEMALE WITH PAST MEDICAL HISTORY OF DIABETES (TYPE NOT SPECIFIED), PERIPHERAL VASCULAR DISEASE, AND RENAL FAILURE (UNSPECIFIED) UNDERWENT A BALLOON ANGIOPLASTY OF THE RIGHT ILIAC ARTERY TO CLEAR AN INTRASTENT STENOSIS. DURING THE PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED WHEN INFLATED TO NOMINAL PRESSURE. THE PATIENT REQUIRED A CUT-DOWN PROCEDURE IN ORDER TO REMOVE THE COMPLAINT DEVICE. THE PROCEDURE BEGAN BY ACCESSING THE LEFT GROIN IN A CONTRALATERAL MANNER IN ORDER TO REACH THE STENTED RIGHT COMMON ILIAC ARTERY. THE STENT WAS PRESENT IN THE DISTAL COMMON ILIAC ARTERY INTO THE EXTERNAL ILIAC ARTERY. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS INSERTED THROUGH A 6FR (FRENCH) SHEATH INTO THE TREATMENT AREA AND INFLATED TO NOMINAL PRESSURE WHEN IT RUPTURED CIRCUMFERENTIALLY. THE ARTERY WAS BEING BALLOONED ABOVE THE STENT. REPORTEDLY, THERE SEEMED TO BE A FRACTURE OF THE STENT ON THE OUTSIDE WALL DISTAL TO THE BALLOONED PORTION OF THE ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE COMPLAINT DEVICE BUT IT WOULD NOT MOVE BACKWARD OR FORWARD ON THE 0.35 WIRE, NECESSITATING BOTH THE WIRE AND THE COMPLAINT DEVICE BEING REMOVED TOGETHER. BOTH THE COMPLA

  Patient problems: No Code Available

  MAUDE report 7886175 ↗