Advance G52333Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002523330), received between May 12, 2016 and Mar 16, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• MalfunctionMar 16, 2021Material Rupture; Material Rupture

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495676 ↗
• InjuryNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING A VENOPLASTY PROCEDURE WHERE ACCESS WAS GAINED VIA RADIAL AND ILIAC ARTERIES USING FLOSSING TECHNIQUE, THE VALVE OF THE ADVANCE 35LP LOW-PROFILE PTA BALLOON DILATATION "CATHER" SEPARATED. ACCORDING TO THE INITIAL REPORTER, THE ROADRUNNER WIRE GUIDE WAS INITIALLY INTRODUCED VIA RADIAL ACCESS, WHILE AN ADVANCE 35LP LOW-PROFILE PTA BALLOON DILATATION CATHER WAS USED TO DILATE THE SUBCLAVIAN. AN ACCESS POINT WAS THEN GAINED IN THE PATIENT'S GROIN, WHERE THE BALLOON DEVICE WAS USED AGAIN TO DILATE THE GROIN SITE. AS THE BALLOON DEVICE WAS BEING REMOVED FROM THE GROIN, THE PHYSICIAN FELT SOME RESISTANCE FROM THE RADIAL END. AS MORE FORCE WAS APPLIED, THE PHYSICIAN THEN CONCLUDED THAT THE BALLOON DEVICE WAS "STUCK" ON THE ROADRUNNER WIRE GUIDE. THE VALVE OF THE ADVANCE 35LP LOW-PROFILE PTA BALLOON DILATATION CATHER, DESCRIBED AS THE PORTION OF THE DEVICE WHERE THE WIRE GUIDE IS INSERTED, WAS SAID TO HAVE "SNAPPED" OFF THE BALLOON CATHETER AND ALL DEVICES WERE REMOVED FROM THE PATIENT TOGETHER. ADDITIONALLY, IT WAS REPORTED THAT PRIOR TO PULLING ALL DEVICES OUT TOGETHER, THE PHYSICIAN REMOVED THE "INTRODUCTION SHEATH." THIS IS WHEN HE OBSERVED THE "WHITE COVER" TO HA

  Patient problems: No Code Available

  MAUDE report 8047362 ↗
• MalfunctionAug 1, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WITH AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED (CAPTURED IN MEDWATCH WITH MFR NUMBER 1820334-2017-01818) AND THE CATHETER SEPARATED (CAPTURED IN THIS MEDWATCH WITH MFR NUMBER 1820334-2017-02248). NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6758107 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE WITH AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON POPPED. ANOTHER BALLOON WAS OPENED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WERE NO REPORTED ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6733658 ↗
• MalfunctionJan 9, 2017Material Rupture; Material Rupture

  DURING A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) PROCEDURE TO TREAT THE BK (BELOW KNEE) ECCENTRIC CTO (CHRONIC TOTAL OCCLUSION) IN THE SFA (SUPERIOR FEMORAL ARTERY). THE DEVICE WAS ADVANCED FROM THE RIGHT GROIN OVER A 0.035" WIRE GUIDE AND INFLATED. HOWEVER, THE BALLOON RUPTURED AT NOMINAL PRESSURE. THEN, IT WAS CHANGED WITH ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6232614 ↗
• MalfunctionMay 12, 2016Material Rupture; Material Rupture

  THE DEVICE WAS ADVANCED IPSILATERALLY TO THE MIDDLE OF THE SFA. WHEN THE BALLOON WAS INFLATED NEARLY AT THE RATED BURST PRESSURE, IT RUPTURED. (IT CANNOT BE DETERMINED IN WHICH DIRECTION, CIRCUMFERENTIAL OR LONGITUDINALLY, THE BALLOON RUPTURED) ANOTHER MANUFACTURER'S DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5651351 ↗