Advance G52342Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002523422), received between Jul 27, 2017 and Jul 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionJul 27, 2017Bent; Inflation Problem

  DURING AN SFA (SUPERFICIAL FEMORAL ARTERY) PROCEDURE, THE COMPLAINANT CHECKED FOR A HOLE IN THE CATHETER AFTER NOTING INSUFFICIENT PRESSURE AND THE INABILITY TO INFLATE THE BALLOON. FURTHER REVIEW OF THE DEVICE NOTED THAT THE CATHETER WAS PINCHED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747309 ↗