Advance Micro G26724Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002267241), received between Jun 15, 2018 and May 9, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS REPORTED, PRIOR TO USE DURING AN ANGIOPLASTY PROCEDURE INVOLVING THE RIGHT PELVIC LIMB, AN UNKNOWN METAL FILAMENT WAS FOUND INSIDE OF AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER. THE PACKAGE WAS OPENED AND THE PLASTIC COVER WAS REMOVED FROM THE DISTAL CATHETER. THE USER THEN ATTEMPTED TO FLUSH THE DEVICE; HOWEVER, THE CATHETER WOULD NOT FLUSH, AS A LONG METAL FILAMENT WAS NOTED INSIDE THE CATHETER LUMEN. THE FILAMENT WAS REPORTEDLY VERY DIFFICULT TO REMOVE AND APPEARED TO BE STUCK TO THE "PLASTIC MEMBRANE" OF THE CATHETER. THE USER WAS ABLE TO FLUSH THE CATHETER ONCE THE FILAMENT WAS SEPARATED FROM THE DEVICE. THE USER THEN ATTEMPTED TO INFLATE THE BALLOON OUTSIDE OF THE PATIENT; HOWEVER THE BALLOON INFLATED IRREGULARLY, WITH SOME LIQUID REMAINING IN PARTS OF THE BALLOON AFTER DEFLATION. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14338346 ↗
• InjuryApr 10, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 10APR2020. AN UNKNOWN 6 FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNKNOWN DEVICE WAS USED TO INFLATE THE BALLOON, USING A 50/50 SOLUTION OF OPTIRAY CONTRAST AND SALINE, TO 6-8 ATMOSPHERES. IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS INFLATED; HOWEVER, THE BALLOON WAS REMOVED FROM THE BODY BETWEEN INFLATIONS. THE BALLOON WAS REPORTEDLY REMOVED WITH THE SHEATH AS A UNIT. LESIONS WERE LOCATED IN THE DISTAL SUPERFICIAL AND POPLITEAL ARTERIES, AS WELL AS THE TIBIOPERONEAL TRUNK. THE VESSELS WERE MILD TO MODERATELY CALCIFIED, BUT WERE NOT TORTUOUS. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT.

  Patient problems: No Code Available

  MAUDE report 9947977 ↗
• MalfunctionJun 15, 2018Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606988 ↗