Advance G52281Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002522814), received between Nov 14, 2018 and Nov 14, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A PERIPHERAL ANGIOPLASTY PROCEDURE TWO ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DEVICES RUPTURED. ACCORDING TO THE INITIAL REPORTER, THE RUPTURES OCCURRED ON THE BACK TABLE, DURING PREP, AND THE DEVICES NEVER MADE PATIENT CONTACT. IT WAS REPORTED THAT THE BALLOONS WERE INFLATED USING A MIX OF 2CC OF CONTRAST WITH 8 CC OF SALINE. IT WAS STATED THAT BOTH OF THE BALLOONS BURST AT 2-3 ATMS. IT IS UNKNOWN WHICH DIRECTION THE RUPTURES OCCURRED. ADDITIONALLY, A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. SEE THE MANUFACTURER REPORT NUMBER 1820334-2018-03229 FOR THE FIRST BALLOON. THIS REPORT IS FOR THE SECOND BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 8072240 ↗