Advance G52253Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522531), received between Jul 27, 2017 and Sep 22, 2020 — classified as 3 malfunctions.

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 16, 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.

• MalfunctionSep 22, 2020Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 28SEP2020. THE PROCEDURE WAS AN ARTERIOGRAM OF THE LOWER EXTREMITY WITH BALLOON DILATION AND STENT IMPLANTATION WITHIN AN 80% OCCLUDED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A 6 FRENCH SHEATH WAS USED DURING THE PROCEDURE AS WELL AS AN UNKNOWN INFLATION DEVICE. THE BALLOON WAS INFLATED ONE TIME FOR TEN SECONDS, USING A 50% SOLUTION OF LODIXANOL, PRIOR TO RUPTURING LONGITUDINALLY. THE BALLOON WAS REMOVED BY ITSELF. NO ANGULATION OR TORTUOSITY WERE NOTED; HOWEVER, THE ANATOMY WAS SLIGHTLY CALCIFIED. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570144 ↗
• MalfunctionOct 19, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A NON-STENT ANGIOPLASTY. IT WAS REPORTED THAT THE BALLOON'S NOMINAL PRESSURE WAS 14 AND RUPTURED WHILE BEING INFLATED. THE RUPTURE WAS REPORTED TO HAVE OCCURRED PRIOR TO REACHING THE MAXIMUM PRESSURE. 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 6963197 ↗
• MalfunctionJul 27, 2017Calcified; Inflation Problem

  THE DEVICE WAS ADVANCED FROM THE RIGHT FEMORAL ARTERY TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN ENCOUNTERED DIFFICULTY IN MANIPULATING THE WIRE GUIDE DUE TO MODERATE CALCIFICATION, BUT FINALLY PASSED OVER THE BIFURCATION. THEN, AN ATTEMPT WAS MADE TO DILATE THE BALLOON. THE BALLOON WOULD NOT INFLATE. ANOTHER BALLOON CATHETER WAS USED 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 6748627 ↗