Advance G52273Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002522739), received between Jun 4, 2020 and May 16, 2022 — classified as 3 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.

• MalfunctionMay 16, 2022Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation

  AS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND TIRE IN HALF. THE HIGHLY CALCIFIED LESION WAS AT THE COMMON ILIAC ARTERY AND STENTED WITH AN UNKNOWN MANUFACTURER'S STENT. THE BALLOON WAS INSERTED THROUGH AN UNKNOWN MANUFACTURER'S 7FR SHEATH WITH ANOTHER MANUFACTURER'S GUIDE WIRE, INFLATED TO 7 ATMOSPHERES, AND SUBSEQUENTLY RUPTURED AND SEPARATED. THE BALLOON WAS REMOVED BY THE USER AND ALL PORTIONS OF THE DEVICE WERE CAPTURED INTO THE SHEATH. BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE BALLOON WAS INFLATED INSIDE A STENT PRIOR TO THE RUPTURE. A SECOND ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING THE SAME PROCEDURE AND WILL BE REPORTED UNDER COOK REFERENCE # (B)(4). THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14411106 ↗
• MalfunctionMar 1, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11392425 ↗
• MalfunctionJun 4, 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 10119435 ↗