Advance G52252Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002522524), received between Jul 19, 2016 and Jun 6, 2019 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED ON 31MAY2019 NOTING: AN UNKNOWN 6 FRENCH SHEATH WAS UTILIZED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS INFLATED TWO TIMES TO 8 ATMOSPHERES FOR 60 SECONDS EACH TIME IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, WITH A 50%/50% RATIO OF VISIPAQUE CONTRAST TO SALINE. THE PATIENT¿S ANATOMY WAS NOT REPORTED TO BE TORTUOUS OR ANGULATED; HOWEVER SEVERE CALCIFICATION WAS REPORTED. THE BALLOON WAS NOT INFLATED INSIDE OF A STENT AND WAS NOT REMOVED BETWEEN INFLATIONS. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8675976 ↗
• MalfunctionApr 2, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LEAKED DURING AN ANGIOPLASTY PROCEDURE (VASCULATURE NOT SPECIFIED). ANOTHER BALLOON WAS USED TO 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 7390184 ↗
• MalfunctionAug 2, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED FOR THE TREATMENT OF CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA). CONTRALATERAL APPROACH WAS GAINED FROM THE GROIN TO TREAT THE SFA. CTO WAS OBSERVED FROM THE ORIGIN OF THE SFA TO THE POP ARTERY. SEVERE CALCIFICATION WAS OBSERVED AS WELL. TERUMO'S DESTINATION SHEATH WAS SELECTED INSTEAD OF COOK'S ANSEL SHEATH SINCE CALCIFICATION WAS SEVERE. THE DESTINATION AND ASAHI INTECC'S CORSAIR 0.014" WERE ADVANCED TO THE TARGET SITE THROUGH THE TRUE LUMEN, BUT THEY COULD NOT PASS DUE TO SEVERE CALCIFICATION. THEREFORE, THESE WERE REPLACED WITH TERUMO'S RADIFOCUS 0.035" AND COOK'S CXI 4FR (=COMPLAINT DEVICE) IN ORDER TO PERFORM KNUCKLE WIRE TECHNIQUE. RADIFOCUS 0.035" AND CXI WERE ADVANCED, BUT THEY COULD NOT PASS THROUGH THE ACCESS ROUTE DUE TO SEVERE CALCIFICATION AND THE CXI GOT KINKED AT THAT TIME. THEN, ANOTHER CXI WAS USED INSTEAD AND IT COULD PASS THROUGH THE ACCESS ROUTE. AFTER THAT, PTA5 WAS ADVANCED TO THE LESION TO TREAT THE SFA BUT IT RUPTURED. THEN, THE 0.035" RADIFOCUS WAS CHANGED WITH A 0.014" WIRE GUIDE AND PTA 14LP BALLOON WAS USED INSTEAD FOR PRE-DILATION AND POST-DILATION BEFORE AND AFTER STENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6759558 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

  A FISTULOGRAM WAS BEING PERFORMED VIA THE UPPER ARM OF A PATIENT, AND A PHYSICIAN WAS USING A LOW PROFILE BALLOON CATHETER WITH EQUAL PARTS ISOVIEW 300 AND SALINE. IT WAS REPORTED THAT DURING THE PROCEDURE THE BALLOON BURST AT LOWER THAN THE BURST PRESSURE. WHEN ASKED WHAT THE INFLATION PRESSURE WAS, IT WAS PROVIDED BY THE COMPLAINANT THAT THEY WERE "NOT SURE BUT BELOW BURST PRESSURE." NO ADVERSE EFFECTS WERE REPORTED PRIOR TO THE OCCURRENCE, AND NO ADDITIONAL PROCEDURES WERE NEEDED.

  Patient problems: No Information

  MAUDE report 6713462 ↗
• InjuryJan 23, 2017Material Rupture; Material Rupture

  IT WAS REPORTED DURING A PERIPHERAL PLASTY WHILE DILATING WITH THE BALLOON THE BALLOON ALLEGEDLY RUPTURED PRIOR TO REACHING 4 MM. REPORTEDLY THE PROCEDURE WAS SUCCESSFULLY PERFORMED TWO DAYS LATER. 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 Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6269407 ↗
• MalfunctionJan 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED USING AN INFLATION DEVICE A LOW PROFILE BALLOON CATHETER POPPED DURING INFLATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6239664 ↗
• MalfunctionJul 19, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE, THE BALLOON DILATATION CATHETER BURST AT THE PRESSURE RATE OF 10 ATM DURING INFLATION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER BALLOON. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5806319 ↗