Advance G34342Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343426), received between May 16, 2019 and Apr 21, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS INSERTED IN THE LEFT ANTERIOR TIBIAL ARTERY VIA PEDAL ACCESS USING A 6FR SLENDER SHEATH FOR POST-DILATION OF A COOK ZILVER 635 STENT WITHIN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY. THE BALLOON RUPTURED FOLLOWING A SECOND INFLATION FOR LESS THAN A MINUTE TO NOMINAL PRESSURE USING AN INFLATION DEVICE. NO BLOOD WAS NOTED IN THE INFLATION DEVICE FOLLOWING THE RUPTURE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND A NEW BALLOON WAS USED TO CONTINUE TO PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166145 ↗
• MalfunctionMay 16, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, A PATIENT OF UNKNOWN GENDER OR AGE WAS UNDERGOING AN ANGIOPLASTY PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA). AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE PROXIMAL SFA WHERE THE LESION WAS APPROXIMATELY EIGHTY PER CENT OCCLUDED. THERE WAS NO VESSEL ANGULATION OR TORTUOSITY. NO CALCIFICATION WAS PRESENT BECAUSE THE AREA WAS PRE-TREATED WITH ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE. THE INITIAL INFLATION WAS EIGHT ATMOSPHERES(ATM). THE BALLOON WAS REPOSITIONED TO A SECOND LESION AND RUPTURED AT THREE ATM. A SIXTY/FORTY RATIO OF CONTRAST TO SALINE WAS USED FOR INFLATION. IT IS UNKNOWN IF THE BALLOON RUPTURED LONGITUDINALLY OR CIRCUMFERENTIALLY. IT IS UNKNOWN IF THERE WAS BLOOD NOTED IN THE INFLATION DEVICE. TYPICAL INFLATION TIME IS ONE MINUTE. THE BALLOON WAS NEVER REMOVED FROM THE VESSEL. IT WAS NOT INFLATED INSIDE A STENT. AN UNKNOWN INFLATION DEVICE AND A COOK 5FR RAABE SHEATH WERE ALSO USED THROUGHOUT THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT BALLOON. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT'S ANATOMY. NO ADDITIONAL PROCEDURES OR ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615963 ↗