Advance Micro G26610Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002266107), received between Feb 7, 2018 and Feb 7, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Hole In Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2018Hole In Material; Material Rupture; Hole In Material; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOGRAM WITH RUNOFF, TWO ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETERS, FROM TWO SEPARATE LOT NUMBERS, RUPTURED DURING INFLATION IN THE POPLITEAL ARTERY. THE FIRST BALLOON CATHETER WAS INFLATED TO 14 ATMOSPHERE (ATM), AND THE SECOND WAS INFLATED TO 8 ATM. PER THE INITIAL REPORTER, THE CORRESPONDING INFLATION PRESSURE OF EACH LOT IS UNKNOWN. IT WAS NOTED THAT HEAVY ARTERIAL CALCIFICATION WAS PRESENT. 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. IT WAS INITIALLY REPORTED THAT BOTH DEVICES WERE FROM THE SAME LOT; HOWEVER, PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018, IT WAS NOTED THAT THE BALLOON CATHETER WAS FROM LOT NUMBER 7363546 (REFER TO MEDWATCH 1820334-2018-00185), AND THE OTHER FROM LOT NUMBER 7939515. MEDWATCH 1820334-2018-00378 DOCUMENTS THE EVENT FOR LOT NUMBER 7939515.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247515 ↗