Advance G52366Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002523668), received between Oct 2, 2017 and Aug 10, 2020 — classified as 5 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.

• MalfunctionAug 10, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN ANGIOPLASTY AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS IN USE WHEN IT BURST AFTER IT HAD BEEN INFLATED TO 8 ATM. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THIS DID NOT RESULT IN ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN AND IF THAT INFORMATION IS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384491 ↗
• MalfunctionMar 18, 2020Material 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 Consequences Or Impact To Patient

  MAUDE report 9848081 ↗
• MalfunctionApr 24, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VASCULAR PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS GAINED FROM THE FEMORAL ARTERY (FA) TO TREAT THE SEVERELY CALCIFIED LESION OF THE COMMON ILIAC ARTERY (CIA). DURING TREATMENT, THE BALLOON RUPTURED AT 4 TO 8 ATMOSPHERES (ATM). THERE WAS NO ANGULATION. IT IS NOT KNOWN WHAT TYPE OF CONTRAST WAS USED OR WHAT THE MIX OF CONTRAST TO SALINE WAS. THE INITIAL REPORTER DID NOT KNOW IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. ACCORDING TO THE INITIAL REPORTER, 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454621 ↗
• MalfunctionOct 5, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED POST ICAST STENT PLACEMENT, WITHIN THE COMMON ILIAC ARTERY. IT WAS REPORTED THAT WHEN THE PHYSICIAN RELEASED NEGATIVE PRESSURE ON THE DEVICE, THERE WAS BLOOD IN THE TUBING INDICATING THE BALLOON HAD RUPTURED. ANOTHER DEVICE WAS USED TO SUCCESSFULLY 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 6918784 ↗
• MalfunctionOct 2, 2017Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  AN INTERNATIONAL CUSTOMER REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) VIA FEMORAL APPROACH, AN UNSPECIFIED STENT GRAFT WAS PLACED IN THE PATIENT. THEN A NON-COOK STENT WAS PLACED IN THE ILIAC ARTERY TO REINFORCE THE LEG OF THE STENT GRAFT. POST-DILATION OF THE NON-COOK STENT WAS CONDUCTED FIRST WITH AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, WHICH WAS USED WITHOUT ANY PROBLEM. THEN, THE PHYSICIAN DILATED THE LESION FURTHER WITH A LARGER-DIAMETER BALLOON. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE TARGET SITE AND INFLATION WAS ATTEMPTED. HOWEVER, THE BALLOON WOULD NOT INFLATE WELL AND RUPTURED AT NOMINAL PRESSURE. IT WAS REPLACED WITH ANOTHER UNSPECIFIED BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908296 ↗