Advance G52351Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002523514), received between Feb 3, 2017 and Jan 15, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2021Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING TREATMENT OF A SEVERELY CALCIFIED, STENOSED LESION IN THE RIGHT COMMON FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. ANOTHER MANUFACTURER'S 6 FRENCH SHEATH WAS ADVANCED FROM THE LEFT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO ACCESS THE RIGHT COMMON FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED THROUGH THE LESION AND WAS INFLATED WITH AN UNKNOWN INFLATION DEVICE TO AN UNKNOWN PRESSURE. BECAUSE RUPTURE WAS SUSPECTED BASED UPON FLUOROSCOPY, THE COMPLAINT DEVICE WAS REMOVED BY ITSELF. A LONGITUDINAL RUPTURE WAS NOTED. ANOTHER MANUFACTURER'S BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE AND THE PATIENT RECOVERED. 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; No Consequences Or Impact To Patient

  MAUDE report 11177352 ↗
• InjuryDec 4, 2018Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8128727 ↗
• MalfunctionAug 28, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED FOR ENDOVASCULAR TREATMENT (EVT) OF A NON-CALCIFIED LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS TO THE SFA WAS GAINED BY IPSILATERAL APPROACH FROM THE LEFT GROIN. IT WAS REPORTED, AFTER A 0.035 INCH WIRE GUIDE PASSED THROUGH THE LESION, THE BALLOON WAS ADVANCED OVER IT AND DILATION OF THE LESION WAS STARTED. HOWEVER, WHEN THE PHYSICIAN APPLIED 6 ATM OF PRESSURE, THE BALLOON RUPTURED. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. 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 6824982 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR AN ENDOSCOPIC THIRD VENTRICULOSTOMY PROCEDURE WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT THE ACCESS SITE FOR THE PROCEDURE WAS FEMORAL, AND AS THE PHYSICIAN BEGAN DILATING THE LESION, THE BALLOON FAILED. THE PRESSURE AT WHICH THE BALLOON WAS INFLATED AT THE TIME OF RUPTURE IS ALLEGEDLY UNKNOWN, BUT ANOTHER PTA BALLOON WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6732445 ↗
• MalfunctionFeb 3, 2017Material Rupture; Material Rupture

  A TREATMENT OF EIA LESION WAS CONDUCTED BY THE IPSILATERAL GROIN APPROACH. AFTER THE TARGET LESION WAS PRE-DILATED WITH A 35LP(6X20), ANOTHER MANUFACTURER'S STENT WAS PLACED. AFTER THE FIRST INFLATION, THE BALLOON WAS DEFLATED AND MOVED TO ANOTHER POSITION IN THE STENT. UPON THE SECOND BALLOONING ATTEMPT, A BALLOON RUPTURE WAS REVEALED. THE PROCEDURE WAS COMPLETED USING ANOTHER 35LP BALLOON(8X20). THE ALLEGED DEVICE WAS USED FOR POST DILATION OF THIS STENT. THE PATIENT REMAINED UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6301213 ↗