Advance Enforcer G35254Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002352541), received between Jul 18, 2017 and Jul 18, 2017 — 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.

• MalfunctionJul 18, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS BEING USED FOR AN IN-STENT RESTENOSIS WHEN IS RUPTURED. IT IS REPORTED THAT THE BALLOON WAS INFLATED TO 16 ATM AT THE TIME OF RUPTURE, AND THE PATIENT'S ANATOMY WAS NOT DESCRIBED TO BE CALCIFIED OR TORTUOUS. ALLEGEDLY, A "MILVUS" DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENT HAVE BEEN REPORTED REGARDING THIS INSTANCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721272 ↗