Advance G52348Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002523484), received between Jul 13, 2017 and Dec 26, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PERIPHERAL ANGIOPLASTY PROCEDURE VIA A CONTRALATERAL APPROACH, THE HUB SEPARATED FROM AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. A TWENTY-MILLILITER SYRINGE WAS USED TO FLUSH THE DEVICE DURING PREPARATION. PER THE REPORTER, MULTIPLE CATHETERS AND BALLOONS USED DURING THE PROCEDURE WERE DIFFICULT TO TRACK THROUGH ANOTHER MANUFACTURER¿S SHEATH, OVER AN UNSPECIFIED ROSEN WIRE GUIDE. THE COMPLAINT DEVICE WAS DIFFICULT TO ADVANCE UP AND OVER A TIGHT BIFURCATION, THROUGH THE OTHER MANUFACTURER¿S SHEATH. PER THE REPORTER, THE PHYSICIAN MENTIONED THAT THE OTHER MANUFACTURER¿S SHEATH MIGHT HAVE MIGRATED INTO THE AORTA, MAKING THE ¿BEND¿ MORE ACUTE. AFTER THE BALLOON WAS USED, ¿A LOT OF¿ RESISTANCE WAS ENCOUNTERED UPON ATTEMPTED REMOVAL OF THE DEVICE OVER A WIRE GUIDE. WITH THE USE OF FORCE TO PULL THE CATHETER, THE HUB SEPARATED. THE BALLOON CATHETER WAS THEN REMOVED WITH THE WIRE GUIDE AS A UNIT, AT WHICH POINT THE USER NOTED THAT THE CATHETER WAS STRETCHED BUT OTHERWISE INTACT. PER THE REPORTER, THE PHYSICIAN ¿DOES NOT THINK THE BALLOON CATHETER WAS THE ISSUE.¿ THE OTHER MANUFACTURER¿S SHEATH WAS EXCHANGED FOR ANOTHER DEVICE, AFTER WHICH THE SURGEON REPORTEDLY FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020585 ↗
• MalfunctionJul 13, 2017Burst Container or Vessel

  THE INFORMATION RECEIVED INDICATED THAT THE BALLOON BURST BEFORE OPTIMUM PRESSURE. THE BALLOON WAS REMOVED, A NEW BALLOON WAS OPENED AND USED. A PIECE OF THE DEVICE DID NOT REMAIN IN THE PATIENT, THE EVENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6711066 ↗