Advance G52301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002523019), received between Jul 13, 2017 and Dec 3, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE INVOLVING BALLOON DILATION OF A STENOSED ILIAC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER SEPARATED. THE ANATOMY WAS REPORTEDLY SLIGHTLY STENOSED. A COOK 10-FRENCH SHEATH WAS ALSO USED DURING THE PROCEDURE. PER THE REPORTER, AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO FIVE ATMOSPHERES. THE BALLOON WAS INFLATED TWO TIMES, FOR TWO MINUTES EACH TIME, TO GRADUALLY DILATE THE LESION, WHICH WAS REPORTEDLY SEVENTY PERCENT OCCLUDED. DURING DILATION, THE BALLOON CATHETER SUDDENLY ¿BROKE¿ WITHIN THE VESSEL. THE USER IS REPORTEDLY UNSURE IF THE BALLOON RUPTURED PRIOR TO SEPARATION OF THE CATHETER; HOWEVER, BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. ONCE DEFLATED, THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE, AND NEGATIVE PRESSURE WAS MAINTAINED UPON ATTEMPTED REMOVAL OF THE DEVICE. THE USER ATTEMPTED TO REMOVE THE BALLOON CATHETER AND SHEATH AS A UNIT. A COUNTERCLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED UPON REMOVAL. THE SEPARATED CATHETER FRAGMENTS WERE SUCCESSFULLY REMOVED WITH AN UNSPECIFIED FILTER RETRIEVAL DEVICE, VIA A JUGULAR APPROACH TO THE INFERIOR VENA CAV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835847 ↗
• MalfunctionJul 13, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  WHILE PERFORMING INTERVENTIONAL VENOUS STENTING, IT WAS REPORTED THAT A PINHOLE LEAK WAS OBSERVED IN THE PROXIMAL PART OF THE BALLOON MATERIAL OF THE LOW PROFILE BALLOON CATHETER. IT WAS PROVIDED THAT THE PATIENT'S VENOUS ANATOMY WAS NOT CALCIFIED, AND A 50/50 MIXTURE OF CONTRAST AND SALINE WAS USED IN THE BALLOON. NO ADVERSE EFFECTS HAVE BEEN REPORTED, AND THERE WAS NO NEED FOR ADDITIONAL PROCEDURES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710229 ↗