Advance G50233Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002502335), received between Sep 19, 2017 and Nov 2, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY OF THE LOWER EXTREMITY FOR A POPLITEAL LESION, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE, AND THE PATIENT WAS REPORTED TO HAVE VESSEL CALCIFICATION. TWO BALLOON CATHETERS RUPTURED DURING THE PROCEDURE, REFER TO MDR 1820334-2017-03677 FOR ADDITIONAL REPORT. THE ANGIOPLASTY WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH ANOTHER COOK MEDICAL BALLOON CATHETER. 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 6996846 ↗
• MalfunctionSep 19, 2017Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY. IT WAS REPORTED, DURING INFLATION, CONTRAST LEAKED FROM THE TIP OF THE BALLOON. THE BALLOON LEAK, WHICH THE PHYSICIAN BELIEVES TO BE A PINHOLE, WAS NOTICED PRIOR TO INFLATION AT NOMINAL 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 6875882 ↗