Advance G50325Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002503257), received between Jul 21, 2017 and Apr 17, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 17, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; 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 16751576 ↗
• MalfunctionAug 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303203 ↗
• MalfunctionNov 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, A FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH STRETCHED DURING AN AORTOGRAM WITH RUNOFF PROCEDURE (REFER TO REPORT REFERENCE NUMBER 1820334-2018-03189). ADDITIONALLY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER INFLATED WITH AN UNSPECIFIED MIXTURE OF SALINE TO CONTRAST, RUPTURED (REFER TO THIS REPORT). ACCORDING TO THE INITIAL REPORTER, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS INSERTED IN THE COMMON FEMORAL ARTERY, CONTRALATERALLY AND UP-AND-OVER. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS PLACED BELOW THE KNEE (BK) IN THE TIBIAL VESSEL. IT WAS REPORTED, THE BALLOON DEVICE WAS INFLATED IN THE PATIENT'S SOMEWHAT TORTUOUS ANATOMY, AND BURST BEFORE REACHING RATED BURST PRESSURE. IT IS UNKNOWN WHETHER THE PATIENT'S ANATOMY WAS CALCIFIED, AS THE PHYSICIAN COULDN'T RECALL SPECIFICS OF THE INCIDENT WHEN THE AREA REPRESENTATIVE FOLLOWED UP IN ATTEMPT TO GET MORE DETAILS. THE RUPTURED ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED OVER AN UNSPECIFIED WIRE GUIDE WITHOUT ISSUE, AND REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS THE PROCEDURE WAS FINISHING UP, THE PHYSICIAN EXPERIENCED SOME DIFFICULTY REMOVING THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH FRO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8053231 ↗
• InjuryJul 21, 2017Air Leak; Air Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF TIBIAL ARTERIES, THE BALLOON WOULD NOT STAY INFLATED. THE BALLOON WAS REMOVED AND TESTED OUTSIDE OF THE PATIENT, AT WHICH TIME AN AIR LEAKAGE FROM THE INFLATION HUB CONNECTOR WAS CONFIRMED. A CONTRALATERAL TECHNIQUE WAS TAKEN DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS SOME CALCIFICATION AND NORMAL ANATOMY IN THE TIBIAL ARTERY. THE DEVICE WAS REPLACED, AND THE ANGIOPLASTY WAS CONTINUED FOR ANOTHER HOUR WITH NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6730950 ↗