Advance G50267Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002502670), received between Mar 1, 2016 and Nov 6, 2018 — classified as 1 injury, 1 malfunction.

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

• MalfunctionNov 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, A FEMALE IN HER 70'S UNDERWENT A LOWER EXTREMITY ANGIOGRAM PROCEDURE IN WHICH THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED. AN ANSEL SHEATH WAS ADVANCED UP AND OVER THE AORTIC BIFURCATION TO THE PATIENTS LEFT COMMON ILIAC ARTERY (CIA). SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF THE LEFT EXTERNAL ILIAC ARTERY (LEIA) WAS PERFORMED WITH BOTH A COOK ADVANCE 18 LP LOW PROFILE BALLOON CATHETER 6X40MM BALLOON AND ANOTHER MANUFACTURER'S 7X40MM DRUG COATED BALLOON (DCB). THE PHYSICIAN ATTEMPTED TO ANGIOPLASTY WITH THE 8X40MM ADVANCE 18 LP LOW PROFILE BALLOON CATHETER 80CM SHAFT AND THE BALLOON RUPTURED LONGITUDINALLY ONCE IT REACHED 10 ATMOSPHERES (ATM) FOR 10 SECONDS. ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER 8X40MM BALLOON, 135CM SHAFT, WAS INSERTED AND TAKEN TO 10ATM FOR 2 MIN WITHOUT COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A COOK INFLATION DEVICE WAS USED TO INFLATE THE COMPLAINT DEVICE. A MIXTURE OF 70% CONTRAST TO 30% NORMAL SALINE SOLUTION WAS IN USE. MILD TO MODERATE CALCIFICATION WAS PRESENT IN THE TREATED ARTERY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8044300 ↗
• InjuryMar 1, 2016Material Rupture; Material Rupture

  DURING A VENA SUBCLAVIAN BALLOONING PROCEDURE ON THE (B)(6) YEAR OLD MALE PATIENT (WHO HAD HIGHLY FIBROTIC TISSUE); THE BALLOON BURST (18-20 ATM INFLATION WAS USED). WHEN REMOVING THE BALLOON IT SNAPPED FROM THE TIP WITH 1-1.5 CM OF THE BALLOON REMAINING IN THE BODY. THE PART WAS SUCCESSFULLY REMOVED WITH SNARE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5470894 ↗