Advance G34337Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002343372), received between Aug 24, 2017 and Aug 24, 2022 — 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.

• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. A COOK INFLATION DEVICE WAS USED TO INFLATE THE BALLOON ONE TIME TO EIGHT ATMOSPHERES, AT WHICH POINT THE BALLOON RUPTURED. THE LESION, WHICH WAS LOCATED IN THE MID-SFA, WAS REPORTEDLY EIGHTY-PERCENT OCCLUDED/STENOSED, AND THE ANATOMY WAS EXTREMELY CALCIFIED. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. ALTHOUGH A COOK SHEATH WAS USED, THE BALLOON WAS REMOVED FROM THE PATIENT BY ITSELF, WHILE MAINTAINING NEGATIVE PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, A PINHOLE WAS NOTED IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287360 ↗
• MalfunctionApr 25, 2019Material 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 8550189 ↗
• MalfunctionAug 24, 2017Material Rupture; Material Rupture

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVICE WAS USED IN A LEG PROCEDURE VIA RETROGRADE AT ACCESS. IT WAS REPORTED THAT THE BALLOON BURST AT LOW INFLATION IN THE SFA LESION. DURING THE SAME PROCEDURE, IT WAS REPORTED THAT ANOTHER SIMILAR ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVICE WAS ALSO USED AND THE BALLOON ALLEGEDLY BURST AT LOW INFLATION IN THE SFA LESION AS WELL. BECAUSE OF THE DIFFERING LOT NUMBERS, THIS DEVICE HAS BEEN REPORTED UNDER (B)(4) AND MANUFACTURER REPORT NUMBER 1820334-2017-02704. 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 6816706 ↗
• MalfunctionAug 24, 2017Material Rupture; Material Rupture

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED IN A LEG PROCEDURE VIA RETROGRADE AT ACCESS. IT WAS REPORTED THAT THE BALLOON BURST AT LOW INFLATION IN THE SFA LESION. DURING THE SAME PROCEDURE, IT WAS REPORTED THAT ANOTHER SIMILAR ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVICE WAS ALSO USED AND THE BALLOON ALLEGEDLY BURST AT LOW INFLATION IN THE SFA LESION AS WELL. BECAUSE OF THE DIFFERING LOT NUMBERS, THIS DEVICE HAS BEEN REPORTED UNDER PR (B)(4) AND MANUFACTURER REPORT NUMBER 1820334-2017-02703. 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 6816698 ↗