Advance G52372Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002523729), received between Dec 5, 2014 and Mar 9, 2022 — classified as 1 injury, 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 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.

• MalfunctionMar 9, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF A STENT WITHIN THE COMMON ILIAC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY UPON THE FIRST INFLATION WITHIN A COOK 16-MILLIMETER STENT. THE PATIENT HAD A HISTORY OF VENOUS DISEASE, AND THE ANATOMY WAS CALCIFIED (PER INTRAVENOUS ULTRASOUND). AN UNSPECIFIED 8 FRENCH, 13-CENTIMETER COOK SHEATH WAS USED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS INFLATED TO ELEVEN ATMOSPHERES, USING AN UNKNOWN INFLATION DEVICE, TO PRE-DILATE THE COMMON ILIAC VEIN (WITHIN THE STENT) AT THE TIME OF RUPTURE. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS REMOVED THROUGH THE SHEATH, AND ANOTHER MANUFACTURER'S 10-MILLIMETER BALLOON WAS USED TO SUCCESSFULLY FINISH THE PROCEDURE AND PLACE AN UNSPECIFIED COOK 10-MILLIMETER STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710185 ↗
• MalfunctionDec 19, 2016Material Rupture; Material Rupture

  IT WAS REPORTED DURING A FISTULA PROCEDURE THE LOW PROFILE CATHETER BALLOON POPPED WHEN BALLOONING THE FISTULA. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 6186862 ↗
• MalfunctionAug 8, 2016Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE LOW PROFILE BALLOON CATHETER SECTION THAT CONNECTED THE PART OF BALLOON AND CATHETER WAS ROUGH AND FAILED TO GO THROUGH THE VESSEL SHEATH DURING THE PROCEDURE. THE BALLOON WAS WITHDRAWN FROM THE PATIENT AND THE OPERATION WAS CANCELLED AS ANOTHER DEVICE WAS NOT AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN AT THE TIME OF THIS REPORT IF ANOTHER PROCEDURE WAS PERFORMED AT A LATER DATE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5852947 ↗
• InjuryDec 5, 2014Balloon rupture

  A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Nonresorbable materials, unretrieved in body

  MAUDE report 4335984 ↗