Advance G50320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002503202), received between Mar 7, 2017 and Jun 14, 2018 — 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.

• MalfunctionJun 14, 2018Material Rupture; Failure to Advance

  THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED CONTRALATERALLY TO THE "BK" LESION, BUT THE BALLOON WOULD NOT ADVANCE THROUGH THE LESION. ANOTHER MANUFACTURER'S DEVICE WAS USED TO PERFORM THE "POBA." THE PHYSICIAN ADVANCED THE BALLOON TO THE LESION AND PERFORMED "POBA" IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE. HOWEVER, THE BALLOON RUPTURED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601840 ↗
• MalfunctionMar 31, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A DILATION PROCEDURE USING AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER THE BALLOON RUPTURED PRIOR TO REACHING 8 ATMOSPHERE (ATM) NOMINAL PRESSURE. THE DIRECTION OF THE BALLOON RUPTURE WAS UNSPECIFIED. THE DEVICE WAS BEING USED IN AN ATTEMPT TO DILATE AN 80% STENOSED LEFT ANTERIOR TIBIAL ARTERY BY IPSILATERAL APPROACH FROM THE LEFT FEMORAL ARTERY (FA). THERE WAS NO SIGNIFICANT CALCIFICATION IN THE LESION. ONCE THE BALLOON WAS OBSERVED TO BE RUPTURED, IT WAS THEN REPLACED WITH COOK'S 4 CM BALLOON WITH THE SAME DIAMETER TO PERFORM THE DILATION. THE PROCEDURE WAS THEN COMPLETED AND THE PATIENT REPORTEDLY HAD A FAVORABLE OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450237 ↗
• MalfunctionMar 7, 2017Leak/Splash; Leak/Splash

  DURING A PROCEDURE USING AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER, THE PHYSICIAN EXPERIENCED AN ISSUE WITH THE HUB LEAKING. THE HEALTH PROFESSIONAL HAD GAINED ACCESS FROM THE CENTRAL FEMORAL ARTERY IN ORDER TO USE THIS DEVICE. IT WAS NOTICED THAT UPON INFLATION OF THE BALLOON CATHETER THAT CONTRAST MEDIA WAS LEAKING FROM THE HUB. THE CATHETER WAS REPLACED AT THAT TIME WITH A COMPETITOR'S PRODUCT AND THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6385066 ↗