Advance G52271Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002522715), received between Feb 21, 2019 and Feb 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING AN ANGIOPLASTY PROCEDURE OF TWO STENTS (MANUFACTURER UNKNOWN) DUE TO IN-STENT RESTENOSIS. THE LESION WAS LOCATED IN THE (B)(6) MALE'S COMPLETELY OCCLUDED LEFT POPLITEAL ARTERY. ACCESS WAS GAINED FROM THE RIGHT GROIN. THE RUPTURE OCCURRED WHEN ATTEMPTING TO DEFLATE THE BALLOON INSIDE THE STENT. THE BALLOON WAS UNABLE TO COMPLETELY ENTER THE COOK 6FR SHEATH FOR REMOVAL BECAUSE IT APPEARED TO "BALL UP" AT THE END. THE BALLOON DID TRACK OVER ANOTHER MANUFACTURER'S 0.14 WIRE AND WAS REMOVED WITH THE SHEATH (ALTHOUGH NOT COMPLETELY INSIDE THE SHEATH). THE BALLOON DID NOT SEPARATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHEATH AND ANOTHER BALLOON. ACCORDING TO THE INITIAL REPORTER, ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED. THE TYPE AND RATIO OF CONTRAST WAS UNKNOWN. ONLY ONE INFLATION WAS PERFORMED; THE PRESSURE WAS OVER NOMINAL PRESSURE BUT NOT OVER BURST PRESSURE. THE PATIENT'S VESSEL WAS NEITHER TORTUOUS NOR CALCIFIED. THERE WAS NO ANGULATION PRESENT. IT IS NOT CERTAIN IF THE COMPLAINT DEVICE RUPTURED LONGITUDINALLY OR CIRCUMFERENTIALLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECT NOR REQUIRE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358203 ↗