Advance G34377Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002343778), received between Feb 6, 2018 and Jun 23, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 23, 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 10186502 ↗
• MalfunctionMay 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE VIA THE POPLITEAL AND TIBIOPERONEAL TRUNK ARTERIES, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST AT 10 ATMOSPHERES (ATM) PRESSURE. DEVICE INSERTION WAS NOT DIFFICULT. THERE WAS CALCIFICATION PRESENT, HOWEVER. THE COMPLAINT DEVICE WAS REMOVED IN ITS ENTIRETY. ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7502767 ↗
• MalfunctionMay 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE VIA THE POPLITEAL AND TIBIOPERONEAL TRUNK ARTERIES, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST AT 10 ATMOSPHERES (ATM) PRESSURE. DEVICE INSERTION WAS NOT DIFFICULT. THERE WAS CALCIFICATION PRESENT, HOWEVER. THE COMPLAINT DEVICE WAS REMOVED IN ITS ENTIRETY. ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7502738 ↗
• MalfunctionFeb 6, 2018Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE PATIENT'S DISTAL RIGHT POSTERIOR TIBIAL ARTERY, A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE STENOSIS AND RUPTURED AT AN INFLATION PRESSURE OF APPROXIMATELY SIX (6) ATMOSPHERE (ATM). THE PHYSICIAN NOTICED LEAKING, REMOVED THE BALLOON AND RE-ATTEMPTED WITH ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER OF THE SAME LOT NUMBER, WHICH ALSO RUPTURED AT 6 ATM. A THIRD ADVANCE 35 LP LOW PROFILE BALLOON CATHETER (DIFFERENT LOT NUMBER) AT AN INFLATION PRESSURE OF 10 ATM WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE POSTERIOR TIBIAL ARTERY WAS FILIFORM THROUGHOUT; THE BALLOON CATHETERS WERE INSERTED WITHOUT EFFORT. THE TRAJECTORY WAS LINEAR; NO ARTERIAL CALCIFICATION, ONLY STENOSIS. THE BALLOONS WERE OBSERVED TO HAVE ONE POINT OF LEAKAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 7245634 ↗