Advance G52276Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002522760), received between Oct 17, 2018 and Nov 19, 2018 — classified as 1 injury, 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 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 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING AN UNSPECIFIED PROCEDURE. THIS INFORMATION WAS GATHERED FROM (B)(4) (REPORT REFERENCE NUMBER 1820334-2018-03152). WHEN THE COMPLAINT DEVICE WAS RECEIVED BY THE MANUFACTURER, IT WAS NOTED THERE WERE TWO INCOMPLETE DEVICES INCLUDED IN THE RETURN PACKAGING. THE COMPLAINT DEVICE FROM (B)(4) WAS IDENTIFIED BY ITS SEPARATED STATE, AND LACK OF CATHETER. THE SECOND ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RECEIVED CONSISTED OF THE A RUPTURED BALLOON STILL IN-TACT WITH THE CATHETER PORTION OF THE DEVICE (REFERENCE THIS REPORT). UPON REACHING OUT TO THE FACILITY, THE PHYSICIAN CONFIRMED THAT ONLY ONE BALLOON ((B)(4)) HAD RUPTURED DURING THE PROCEDURE, REQUIRING A SURGICAL CUT-DOWN TO REMOVE THE SEPARATED DISTAL PORTION OF THE DEVICE. THE TREATING PHYSICIAN WAS UNABLE PROVIDE ANY DETAILS SURROUNDING THE SECOND DEVICE. NEITHER THE PHYSICIAN NOR THE AREA REPRESENTATIVE WERE ABLE TO EXPLAIN WHY AN EXTRA BALLOON DEVICE WAS INCLUDED IN THE PACKAGING. THEREFORE, NO PATIENT HARM OR ADVERSE EFFECTS HAVE BEEN REPORTED REGARDING THE DEVICE CAPTURED IN THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087956 ↗
• InjuryOct 17, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INFLATION TO RATED BURST PRESSURE IN A HEAVILY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. A MIXTURE OF CONTRAST TO SALINE WAS USED. PROPORTIONS NOT SPECIFIED. THE TIP OF THE BALLOON BROKE OFF AT SOME POINT WHEN THE USER WAS REMOVING THE BALLOON. THE PHYSICIAN HAD TO DO A CUT DOWN TO REMOVE THE BALLOON TIP WHICH WAS FOUND RIGHT AT THE COMMON FEMORAL ARTERY. 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 Code Available

  MAUDE report 7976609 ↗