Advance G50327Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002503271), received between Nov 16, 2016 and Jun 11, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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.

• MalfunctionJun 11, 2018Detachment Of Device Component

  IT WAS REPORTED THAT THE BALLOON OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER DETACHED FROM THE SHAFT WHILE THE PROTECTIVE SLEEVE WAS BEING REMOVED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7588604 ↗
• MalfunctionFeb 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING ENDOVASCULAR TREATMENT (EVT) OF THE PATIENT'S SEVERELY CALCIFIED LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA), THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED (DIRECTION UNKNOWN) AT AN INFLATION PRESSURE OF 16 ATMOSPHERE (ATM) DURING PRE-DILATION OF THE LESION. ACCESS WAS GAIN VIA IPSILATERAL ANTEGRADE APPROACH FROM THE POPLITEAL ARTERY. ANOTHER BALLOON CATHETER (UNSPECIFIED MANUFACTURER) WAS UTILIZED, AND DILATION WAS CONDUCTED SUCCESSFULLY. 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 7270930 ↗
• MalfunctionOct 25, 2017Material Rupture; Material Rupture

  AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED, THE DEVICE WAS ADVANCED OVER A WIRE GUIDE FROM THE LEFT CENTRAL FEMORAL ARTERY IN ORDER TO TREAT THE CTO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY BY CROSS-OVER APPROACH. WHEN THE PHYSICIAN ATTEMPTED TO DILATE THE CALCIFIED LESION WITH THE DEVICE, THE BALLOON RUPTURED LONGITUDINALLY BEFORE REACHING TO THE NOMINAL PRESSURE. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON TO PERFORM PRE-DILATION FOR STENTING, AND THE PROCEDURE OF STENT PLACEMENT WAS COMPLETED AFTER POST-DILATION WITH ANOTHER NON COOK BALLOON CATHETER. 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 6978381 ↗
• MalfunctionNov 16, 2016Material Rupture; Material Rupture

  IT WAS REPORTED WHEN THE PHYSICIAN WAS DILATING THE TARGET LESION WITH THE BALLOON, THE BALLOON RUPTURED AT THE RECOMMENDED PRESSURE OF 8ATM. THE DEVICE WAS REPLACED WITH ANOTHER BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6106625 ↗