Advance Micro G26719Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002267197), received between Feb 19, 2018 and Sep 5, 2023 — classified as 2 malfunctions.

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

• MalfunctionSep 5, 2023Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED 24OCT2023. DIRECT ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND A CONTRALATERAL APPROACH WAS USED TO TARGET THE POSTERIOR TIBIAL ARTERY. THE BIFURCATION WAS NOT STEEP OR CALCIFIED; HOWEVER, THE ANATOMY WAS STENOSED, WITH CALCIFIED PLAQUES ALONG THE "PATH". A COOK SHEATH WAS USED DURING THE PROCEDURE. THE BALLOON DID NOT RUPTURE, AND BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS RETURNED TO AMBIENT PRESSURE ONCE DEFLATED, AND NEGATIVE PRESSURE WAS MAINTAINED UPON REMOVAL. A COUNTERCLOCKWISE ROTATION OF THE DEVICE WAS NOT CONDUCTED UPON WITHDRAWAL. THE CATHETER FRAGMENTS WERE STUCK TO THE WIRE GUIDE; THEREFORE, THE USER REMOVED THE WIRE GUIDE AND CATHETER PIECES TOGETHER, BY PULLING ON THE WIRE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681992 ↗
• MalfunctionFeb 19, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY, THE ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER HUB DETACHED FROM THE CATHETER SHAFT AS THE CATHETER WAS BEING REMOVED FROM THE PATIENT. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7280585 ↗