Advance G52256Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522562), received between Jan 2, 2020 and Mar 29, 2024 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2024Fluid/Blood Leak; Material Puncture/Hole; Material Rupture; Fluid/Blood Leak; Material Puncture/Hole; Material Rupture

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED WHILE INFLATING DUE TO HEAVY CALCIUM AND CTO (CHRONIC TOTAL OCCLUSION). THE USER WAS ABLE TO TAKE BALLOON OFF THE WIRE AND USE A NEW UNSPECIFIED BALLOON TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005012 ↗
• MalfunctionJan 31, 2024Material 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616791 ↗
• MalfunctionSep 11, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE LEFT DISTAL SUPERFICIAL ARTERY AT THE POPLITEAL, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON THE FIRST INFLATION. THE BALLOON RUPTURED AT "LOW" ATMOSPHERES WITHIN SECONDS OF BEING PLACED. A 6 FRENCH COOK ANSEL SHEATH WAS USED DURING THE PROCEDURE AS WELL AS A COOK INFLATION DEVICE. THE ANATOMY WAS MODERATELY CALCIFIED. THE BALLOON WAS REMOVED OVER THE WIRE GUIDE. BLOOD WAS NOTED WITHIN THE INFLATION DEVICE WHEN THE RUPTURE OCCURRED. THE BALLOON WAS NOT INFLATED WITHIN A STENT. ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. DURING THE SAME PROCEDURE, ANOTHER COOK ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THAT EVENT WILL BE REPORTED UNDER PR (B)(4). 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 Consequences Or Impact To Patient

  MAUDE report 10521007 ↗
• MalfunctionJan 2, 2020Material Rupture; Material Rupture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537808 ↗