Advance G52258Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002522586), received between Jul 17, 2017 and Sep 19, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Crack; Crack

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098160 ↗
• MalfunctionNov 11, 2021Leak/Splash; Leak/Splash

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE AND USING A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE PHYSICIAN NOTED THAT THE DEVICE FELT AS IF THERE WAS A LOT OF AIR COMING INTO THE BALLOON DURING THE PROCEDURE PREPARATION. A 6FRX70 ANSEL SHEATH WAS UTILIZED DURING THE PROCEDURE. BOTH AN INFLATION DEVICE AND SYRINGE WERE USED. THE PHYSICIAN WAS NOT ABLE TO GET THE BALLOON TO NOMINAL PRESSURE. THE DEVICE WAS THEN INTRODUCED INTO THE PATIENT AND IT EXPELLED A LOT OF CONTRAST. THE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A ANOTHER MANUFACTURER'S DEVICE. THE PATIENT'S ANATOMY WAS NOTED TO BE A HEAVILY CALCIFIED LESION, AND THE LESION WAS LOCATED IN THE POPLITEAL ARTERY. THE LESION WAS APPROXIMATELY 90% OCCLUDED. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THE OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED DUE TO THE ALLEGED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797739 ↗
• MalfunctionFeb 5, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11285183 ↗
• InjuryApr 6, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOGRAM PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INFLATION. REPORTEDLY, ACCESS WAS OBTAINED BY CROSSING OVER THE AORTIC BIFURCATION WHICH WAS MILDLY DIFFICULT DUE TO BODY HABITUS AND CALCIFICATION. AN ARTHRECTOMY WAS PERFORMED OF A FOCAL, CALCIFIED, DISTAL STENOSIS OF THE SUPERIOR FEMORAL ARTERY ABOVE THE ADDUCTOR¿S CANAL USING ANOTHER MANUFACTURER¿S DEVICE AND A ZILVER STENT WAS DEPLOYED WITHOUT INCIDENCE. AT THIS TIME, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO POST DILATE THE STENT AND UPON INFLATION TO 14 ATMOSPHERES (ATM), IT RUPTURED. BALLOON REMOVAL WAS REPORTEDLY DIFFICULT. THE PHYSICIAN EXERTED FORCE AND ULTIMATELY REMOVED THE WIRE FOR A SECOND ATTEMPT AT BALLOON REMOVAL. THE SECOND ATTEMPT RESULTED IN THE SHAFT OF THE BALLOON RUPTURING. INCOMPLETE BALLOON REMOVAL WITH A INABILITY TO LOCATE THE BALLOON TIP ALONG WITH CIRCUMFERENTIAL BALLOON TEAR WAS REPORTED. THE PATIENT'S BILATERAL LOWER EXTREMITIES WERE IMAGED WITH X-RAY IN AN ATTEMPT TO VISUALIZE THE TIP; HOWEVER, NO OBJECTS WERE NOTED IN THE VESSELS OR SUBCUTANEOUS TISSUE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL P

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7403980 ↗
• MalfunctionJul 17, 2017Material Rupture

  IT WAS REPORTED THAT CROSSOVER TECHNIQUE WAS PERFORMED AFTER MULTIPLE STENOSES IN THE RIGHT SFA (SUPERFICIAL FEMORAL ARTERY). THERE WASN'T MUCH VESSEL CALCIFICATION, BUT THE BALLOON RUPTURED IN THE STENOSIS AT 6-8 ATM. THE PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) WAS SUCCESSFUL AND THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6719513 ↗