Advance G34332Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002343327), received between Sep 27, 2018 and Aug 23, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionAug 23, 2021Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS ADVANCED TO A 40-50% OCCLUDED SUPERFICIAL FEMORAL ARTERY USING A 5FR ANSEL SHEATH. THE VESSEL WAS MODERATELY CALCIFIED BUT NOT ANGULATED OR TORTUOUS. THE DEVICE WAS INFLATED TO 8 ATMOSPHERES USING AN INFLATION DEVICE WHEN IT RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION 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 12352684 ↗
• InjuryApr 23, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11717440 ↗
• MalfunctionSep 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES DURING AN UNSPECIFIED LEFT POPLITEAL PROCEDURE. THE VESSEL WAS CALCIFIED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ALTHOUGH REQUESTED, NO INFORMATION WAS RECEIVED RELATIVE TO THE MIX OF CONTRAST TO SALINE, LESION LOCATION, OR VESSEL ANGULATION. NO INFORMATION WAS RECEIVED IF THE COMPLAINT DEVICE RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7915761 ↗