Advance G52267Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522678), received between Jul 17, 2017 and Apr 18, 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.

• MalfunctionApr 18, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF A LESION AND IN-STENT STENOSIS WITHIN THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. A COOK SHEATH WAS USED DURING THE PROCEDURE. THE ANATOMY ITSELF WAS REPORTEDLY NOT STENOSED, TORTUOUS, OR CALCIFIED. THE BALLOON WAS INFLATED ONE TIME TO NOMINAL PRESSURE WITHIN THE STENOSED STENT, USING AN UNSPECIFIED INFLATION DEVICE, AT WHICH POINT THE BALLOON RUPTURED. BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON CATHETER WAS SAFELY REMOVED BY ITSELF. THE PHYSICIAN WAS REPORTEDLY ABLE TO ACHIEVE THE DESIRED RESULT WITH THE COMPLIANT DEVICE. A 6X20 COOK BALLOON WAS ALSO USED WITH NO ISSUES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19139432 ↗
• MalfunctionJan 26, 2023Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: Insufficient Information

  MAUDE report 16245689 ↗
• MalfunctionJul 25, 2017Material Discolored; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO ADDRESS A "HARD OCCLUSION". AFTER USING DIFFERENT TECHNIQUES, THE PHYSICIAN WAS ABLE TO USE A CXI CATHETER TO PASS THE OCCLUSION. HOWEVER, THE BALLOON CATHETER WAS NOT EASILY ADVANCED. SUBSEQUENTLY, FORCE WAS NEEDED TO REMOVE THE BALLOON CATHETER FROM THE PATIENT. VISUAL EXAMINATION REVEALED COLOR CHANGES IN THE SHAFT OF THE BALLOON CATHETER. AS A RESULT, THE PHYSICIAN DECIDED NOT TO CONTINUE USING THE BALLOON CATHETER 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6740327 ↗
• MalfunctionJul 17, 2017Material Rupture

  IT WAS REPORTED THAT UPON INFLATION, THE BALLOON RUPTURED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717409 ↗