Advance G52300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002523002), received between Jul 25, 2017 and Jan 26, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2023Material Rupture; Material Separation; Stretched; Material Rupture; Material Separation; Stretched

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

  Patient problems: Foreign Body In Patient

  MAUDE report 16246522 ↗
• MalfunctionMar 12, 2018Kinked; Stretched; Kinked; Stretched

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE WHILE FLUSHING THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WITH SALINE PRIOR TO DILATATION OF ILIAC VEIN, A KINK WAS OBSERVED ON THE PUSH ROD. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER DEVICE WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. UPON MANUFACTURER RECEIPT AND REVIEW OF PROVIDED IMAGING, IT WAS NOTED THAT THE DEVICE APPEARS TO BE STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7330969 ↗
• MalfunctionJul 25, 2017Break; Inflation Problem

  IT WAS REPORTED THAT DURING THE LOWER LIMB ARTERIOSCLEROSIS OBLITERATION PROCEDURE, THE BALLOON WOULD NOT INFLATE. UPON REMOVAL OF THE BALLOON, THE USER FOUND THE BALLOON WAS BROKEN. THE PROCEDURE WAS FINISHED WITH A NEW DEVICE. 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 6739666 ↗