Advance Micro G26626Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002266268), received between Jun 12, 2018 and Feb 2, 2022 — 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.

• MalfunctionFeb 2, 2022Break; Crack; Break; Crack

  AS REPORTED, DURING AN ANGIOGRAM OF THE POPLITEAL ARTERY THE HUB OF A ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER BROKE. THE BALLOON WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S 6FR SHEATH TO THE TARGET LOCATION. IT WAS INFLATED USING AN ADVANTAGE KIT WITH A 50/50 SOLUTION OF SALINE AND CONTRAST. THE HUB OF THE DEVICE THEN BROKE WHILE "TWISTING". THE BALLOON WAS THEN REMOVED AS A UNIT AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. IT WAS NOTED THAT THE ANATOMY WAS NOT TORTUOUS, BUT WAS MODERATELY TO SEVERELY CALCIFIED. 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. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13422741 ↗
• MalfunctionJun 12, 2018Entrapment of Device; Sticking

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER FOR A BELOW THE KNEE PROCEDURE. DURING ADVANCEMENT OF THE CATHETER, IT BECAME STUCK ON THE MICROWIRE AND WOULD NO LONGER MOVE IN EITHER DIRECTION, SO THE WIRE AND CATHETER HAD TO BE REMOVED TOGETHER. IT WAS ALSO LATER NOTED THAT THE CATHETER WAS STRETCHED. NEW DEVICES WERE USED TO CONTINUE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592074 ↗