Advance Micro G26119Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002261195), received between Apr 13, 2018 and Apr 26, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionApr 26, 2019Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED, DURING A RENAL ANGIOGRAM INVOLVING A (B)(6) PATIENT WITH RENAL STENOSIS, AN ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER ELONGATED AND SEPARATED. THE DEVICE WAS REPORTED TO BE FLUSHED WITH 20 MILLILITERS OF SALINE AND ANOTHER MANUFACTURER'S 0.014 INCH GUIDE WIRE WAS "WIPED DOWN". AN UNKNOWN MANUFACTURER'S SHEATH WAS UTILIZED DURING THE CASE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE COMPLAINT DEVICE OVER THE WIRE AND NOTED RESISTANCE UPON ADVANCEMENT. THE PHYSICIAN THEN DECIDED TO REMOVE THE DEVICE OVER THE WIRE. DURING REMOVAL OF THE BALLOON FROM THE WIRE, THE DEVICE "TORE". ELONGATION/STRETCHING WAS NOTED PRIOR TO THE DEVICE SEPARATING INTO "3 OR 4 PIECES". THE DEVICE DID NOT ENTER THE PATIENT'S BODY. NO FURTHER INTERVENTION WAS REQUIRED ONCE THE BALLOON WAS REMOVED FROM THE WIRE. THE DEVICE WAS DISPOSED OF BY THE CUSTOMER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE OF THE SAME TYPE. AS REPORTED, THE PHYSICIAN "STATED THAT SHE FELT THAT SHE MIGHT NOT HAVE HYDRATED IT ENOUGH". 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 IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557887 ↗
• MalfunctionApr 13, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN INTERVENTION OF THE SUPERFICIAL FEMORAL ARTERY (SAFARI PROCEDURE), THE ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER WAS FOUND TO BE LEAKING FROM THE STRAIN RELIEF. THE ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER WAS INSERTED INTO THE UNSPECIFIED PEDAL ACCESS SITE AND DELIVERED IN THE MINIMALLY CALCIFIED ANTERIOR TIBIAL ARTERY. THERE WAS NO ANGULATION. THE BALLOON WAS NOT ABLE TO ACHIEVE NOMINAL INFLATION PRESSURE. IT WAS REMOVED AND A DIFFERENT SIZED ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430190 ↗