Advance G52331Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002523316), received between Jul 12, 2017 and Jul 6, 2020 — classified as 3 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 18, 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.

• MalfunctionJul 6, 2020Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED, PRIOR TO USE DURING AN ANGIOGRAM, THE SEAL WAS NOTED TO BE MISSING FROM AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER PACKAGE. AS THE USER OPENED THE PACKAGE, THE SEAL WAS NOTED TO BE MISSING AND THE BALLOON WAS MISSING FROM THE SHAFT. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT. A NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 10233454 ↗
• MalfunctionJul 6, 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 10233324 ↗
• MalfunctionJul 12, 2017Material Rupture

  THE DEVICE WAS USED TO TREAT A LESION WITH CALCIFICATION. THE BALLOON RUPTURED DURING THE PROCEDURE. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708046 ↗