Advance G34328Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002343280), received between Jan 25, 2017 and Aug 5, 2020 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A STENT PLACEMENT WITHIN THE DISTAL LEFT SFA AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS IN USE WHEN IT WAS FOUND TO BE LEAKING. THE DEVICE WAS BEING INFLATED WITH A COOK INFLATION DEVICE TO A PRESSURE OF 8 ATM WHEN THE USER SAW CONTRAST WITHIN THE VESSEL, WHICH WAS IN THE PATIENT FOR AROUND 20 SECONDS BEFORE THE CONTRAST WAS NOTICED. THE BALLOON WAS THEN DEFLATED AND REMOVED. THE DEVICE WAS THEN TESTED ON THE TABLE AND FOUND THAT THE PROXIMAL BALLOON AREA NEAR THE "SHOULDERS" WAS LEAKING. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT REQUIRE THE PATIENT TO NEED ANY ADDITIONAL PROCEDURES OR PROLONGED HOSPITAL STAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367119 ↗
• MalfunctionDec 31, 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 Consequences Or Impact To Patient

  MAUDE report 8206260 ↗
• MalfunctionJan 25, 2017Material Rupture; Material Rupture

  THIS COMPLAINT WAS REPORTED TO CUSTOMER SERVICE BY A FOREIGN DISTRIBUTOR. IT WAS ALLEGED A BALLOON RUPTURED AT 6 ATM DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AT THE DISTAL SUPERFICIAL FEMOROPOPLITEAL ARTERY (SFA) LOCATION. REPORTEDLY THE BALLOON WAS REMOVED WITHOUT ANY PROBLEMS. THE REPORTER INDICATED THE PATIENTS LESION WAS MODERATELY CALCIFIED BUT NOT TORTUOUS. 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 6277431 ↗