Advance Micro G26407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002264073), received between Jul 17, 2017 and Mar 27, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY VIA ANTEGRADE ACCESS, AN ADVANCE MICRO 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER RUPTURED. ANOTHER MANUFACTURER'S 6-FRENCH SHEATH WAS USED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS REPORTEDLY DIFFICULT TO TRACK TO THE LESION DUE TO CALCIFICATION, WHICH WAS NOTED DURING WIRE ADVANCEMENT AND IMAGING. THE BALLOON CATHETER COULD NOT TRACK MORE THAN SEVEN CENTIMETERS FROM THE START OF THE PROXIMAL SEGMENT OF THE VESSEL. THE BALLOON WAS INFLATED ONE TIME WITHIN A STENOSED LESION IN THE PROXIMAL SECTION OF A CRURAL VESSEL, USING ANOTHER MANUFACTURER'S INFLATION DEVICE, TO APPROXIMATELY SIX-TO-EIGHT ATMOSPHERES; HOWEVER, THE BALLOON RUPTURED LONGITUDINALLY. THE ENTIRE LENGTH OF THE VESSEL WAS SIGNIFICANTLY CALCIFIED AND HAD POOR RUN OFF, WITH "THREADY" AND "PATCHY" FLOW ALONG THE LENGTH OF THE VESSEL. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE DEVICE WAS RETRIEVED THROUGH THE SHEATH, USING AN UNSPECIFIED SNARE. TREATMENT OF OTHER VESSELS WAS COMPLETED WITH ANOTHER BALLOON; HOWEVER, THE VESSEL BEING TREATED AT THE TIME OF THIS EVENT WAS LEFT UNTREATED, DUE TO CALCIFICATION AND OTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988249 ↗
• MalfunctionMay 6, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER OR AGE WAS UNDERGOING AN ANGIOGRAM PROCEDURE USING A ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER OF A LESION IN THE RIGHT ANTERIOR TIBIAL. THE BALLOON BURST AT NOMINAL PRESSURE. A COOK PEDAL ACCESS "2.9FR" SHEATH AND AN INFLATION DEVICE WERE ALSO IN USE. THERE WAS NO VESSEL CALCIFICATION. ALTHOUGH REQUESTED, THE FOLLOWING IS NOT KNOWN: IT IS NOT KNOWN IF THE VESSEL WAS TORTUROUS OR ANGLED; IT IS UNKNOWN HOW MANY TIMES THE BALLOON WAS INFLATED OR HOW LONG EACH INFLATION WAS.; IT IS NOT KNOWN WHAT TYPE OF CONTRAST WAS USED; IT IS NOT KNOWN HOW THE BALLOON WAS REMOVED OR IF IT WAS REMOVED WITH THE SHEATH.; IT IS NOT KNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE BALLOON WAS NOT INFLATED INSIDE A STENT PRIOR TO RUPTURE. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, A PORTION OF THE BALLOON DID NOT REMAIN IN THE PATIENT'S ANATOMY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE OR EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8583723 ↗
• MalfunctionApr 12, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION RECEIVED NOTING THAT NEGATIVE PRESSURE WAS APPLIED WHILE ATTEMPTING TO REMOVE THE BALLOON CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509887 ↗
• MalfunctionJul 17, 2017Burst Container or Vessel

  THE REPORTED INFORMATION INDICATED THAT THE BALLOON BURST LONGITUDINALLY BELOW RATE BURST PRESSURE. THE DEVICE WAS BEING USED IN THE PERONEAL ARTERY AND BURST UPON REACHING 14 ATMOSPHERES. THE PROCEDURE WAS COMPLETED USING A COMPETITORS¿ CORONARY BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY, NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6716682 ↗