Advance G50337Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002503370), received between Jul 16, 2018 and Jan 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionJan 23, 2025Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED 27JAN2025 FROM THE CUSTOMER AND 20FEB2025 VIA A MEDWATCH REPORT SUBMITTED BY THE CUSTOMER. THE PROCEDURE INVOLVED AN AORTOGRAM, BILATERAL LOWER EXTREMITY ANGIOGRAMS, BALLOON ANGIOPLASTY OF THE RIGHT POPLITEAL ARTERY, AND REVASCULARIZATION OF THE LEFT LEG WITH ANGIOPLASTY FROM THE TIBIOPERONEAL TRUNK INTO THE POPLITEAL ARTERY, VIA LEFT FEMORAL ACCESS. ANOTHER MANUFACTURER¿S 6-FRENCH, 90-CENTIMETER SHEATH WAS USED DURING THE PROCEDURE. THE ANATOMY WAS STENOSED, AND THE LESION WITHIN THE POPLITEAL ARTERY WAS 100% OCCLUDED. ANOTHER MANUFACTURER¿S INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO APPROXIMATELY 12-TO-14 ATMOSPHERES WITHIN THE RIGHT TIBIOPERONEAL TRUNK AND PERONEAL ARTERY. AS THE BALLOON WAS INFLATED, THE USER NOTED MARKED OCCLUSIVE DISEASE IN THE TIBIOPERONEAL TRUNK, WHICH, PER THE REPORTER, RUPTURED THE BALLOON CIRCUMFERENTIALLY, BELOW THE RATED BURST PRESSURE, AS PRESSURE WAS RELEASED. AFTER ANGIOPLASTY, MINIMAL FLOW ¿INTO THE SEGMENTS¿ WAS REPORTED WITH BALLOON RUPTURE AND FRAGMENTATION. THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON DEFLATION. THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21220119 ↗
• MalfunctionAug 3, 2022Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEFT LEG, A PINHOLE WAS NOTED ON AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER'S BALLOON UPON THE FIRST INFLATION. AN UNKNOWN 6 FRENCH SHEATH WAS USED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED TO ATTEMPT INFLATION TO EIGHT ATMOSPHERES; HOWEVER, THE BALLOON LOST PRESSURE AND WOULD NOT INFLATE. THE ANATOMY WAS REPORTEDLY CALCIFIED, AND THE LESION IN THE LEFT COMMON ILIAC ARTERY WAS APPROXIMATELY EIGHT PERCENT OCCLUDED. THE BALLOON WAS REMOVED BY ITSELF, AND THE USER TESTED THE BALLOON OUTSIDE THE PATIENT, NOTING THAT SALINE WAS LEAKING FROM A PINHOLE IN THE BALLOON MATERIAL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15156644 ↗
• MalfunctionJul 16, 2018Material Separation; Material Separation

  AN FDA SUS REPORT (MW5078023) WAS RECEIVED 07/02/2018 REPORTING AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BROKE INSIDE THE SHEATH UPON REMOVAL FROM A PATIENT. DURING FOLLOW UP, THE COMPLAINANT REPORTED THE COMPLAINT DEVICE WAS BEING USED TO TREAT A COMPLETE OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH ACCESS GAINED VIA THE PEDAL ROUTE. INITIALLY THE BALLOON PORTION OF THE COMPLAINT DEVICE WAS INFLATED TO TREAT THE LESION IN THE SFA AND WORKED "FLAWLESSLY". THE SECOND INSERTION OF THE COMPLAINT DEVICE WAS PERFORMED WITHOUT DIFFICULTY; HOWEVER, UPON REMOVAL, SOME RESISTANCE WAS ENCOUNTERED. THE TIP OF THE BALLOON COULD NOT BE REMOVED THROUGH THE 4 FRENCH (FR) SHEATH. IT SEPARATED FROM THE SHAFT OF THE COMPLAINT DEVICE. THE 4FR SHEATH WAS REMOVED OVER THE WIRE WITH THE BALLOON PORTION STILL IN THE SHEATH. A NEW 4FR SHEATH WAS PLACED AND THE PROCEDURE WAS CONTINUED AS PLANNED. 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 7691270 ↗