Advance G34323Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002343235), received between Mar 14, 2019 and May 12, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• MalfunctionMay 12, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WOULD NOT HOLD INFLATION. THE BALLOON WAS NEGATIVELY PREPPED PRIOR TO INSERTION BUT NOT INFLATED. UPON INFLATION UNDER FLUOROSCOPY, USING ANOTHER MANUFACTURER'S INFLATION DEVICE, THE BALLOON WOULD NOT REACH THE INTENDED PRESSURE, BUT PARTIAL INFLATION WAS NOTED. THE DEVICE WAS REMOVED AND TESTED OUTSIDE THE PATIENT'S BODY, SHOWING LEAKAGE AND A DROP IN PRESSURE DUE TO A PINHOLE. A NEW BALLOON 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. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14371982 ↗
• MalfunctionSep 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  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 9134204 ↗
• MalfunctionMar 14, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WOULD NOT CROSS THE LESION. DURING PRELIMINARY VISUAL REVIEW OF THE RETURNED COMPLAINT DEVICE, IT WAS NOTED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER IS RUPTURED/SEPARATED INTO PIECES. A (B)(6) FEMALE WITH A 95% CALCIFIED STENOSIS OF THE RIGHT ILIAC WAS UNDERGOING AN UNSPECIFIED PERIPHERAL INTERVENTION PROCEDURE. THE COMPLAINT BALLOON WAS BEING USED FOR PRE-DILATION OF A PROXIMAL ILIAC LESION THAT WAS DESCRIBED AS HAVING AN AREA LIKE "A DISCREET ROCK". THERE WAS ONE INSERTION OF THE BALLOON AND TWO INFLATIONS USING AN UNSPECIFIED MANUFACTURER'S INFLATION DEVICE AND AN INFLATION MEDIUM REPORTED AS ISOVUE 300 CONTRAST IN A 50/50 CONTRAST WITH SALINE. ANOTHER DEVICE IN USE AT THE TIME WAS ANOTHER MANUFACTURER'S FIVE FRENCH SHEATH. THE PATIENT'S ANATOMY WAS NEITHER ANGLED NOR TORTUOUS. THE COMPLAINT BALLOON WAS REMOVED "IN THE NORMAL FASHION". 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 Consequences Or Impact To Patient

  MAUDE report 8422424 ↗