Advance G52293Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002522937), received between Jul 21, 2017 and Nov 26, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• InjuryNov 26, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING ANGIOPLASTY OF A STENOTIC SUBCLAVIAN VEIN AND BRACHIAL FISTULA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED CIRCUMFERENTIALLY AND SUBSEQUENTLY SEPARATED. THE DEVICE WAS USED ONE TIME. PER THE REPORTER, AFTER THE BALLOON RUPTURED, HALF OF THE BALLOON MATERIAL SEPARATED/DISLODGED AND MIGRATED TO THE PATIENT'S LUNG, WHERE IT IS LODGED. REPORTEDLY, THE SEPARATED FRAGMENT CANNOT BE RETRIEVED AND WILL BE LEFT IN THE LUNG. NO ADDITIONAL ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, A PORTION OF THE BALLOON WAS MISSING, AND THE SHAFT WAS SEPARATED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20784202 ↗
• InjuryMar 14, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING BALLOON DILATION OF A STENT IN THE ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE ANATOMY WAS SEVERELY CALCIFIED, AND BOTH ILIAC ARTERIES WERE STENOSED AND GREATER THAN FIFTY PERCENT OCCLUDED. THE BALLOON WAS USED TO DELIVER AND INITIALLY EXPAND ANOTHER MANUFACTURER'S STENT. ANOTHER MANUFACTURER'S PRESSURE PUMP/INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TWO TIMES TO EIGHT ATMOSPHERES, FOR THIRTY SECONDS EACH TIME, TO EXPAND THE STENT; HOWEVER, THE BALLOON RUPTURED CIRCUMFERENTIALLY DURING POSTERIOR EXPANSION OF THE STENT. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. IT WAS REPORTEDLY THEN IMPOSSIBLE TO REMOVE THE BALLOON CATHETER THROUGH ANOTHER MANUFACTURER'S SHEATH, AND THE CUSTOMER CUT THE BALLOON OFF DURING THE "EXTRACTION PROCESS". THE BALLOON WAS REMOVED VIA AN INCISION OF THE RIGHT FEMORAL ARTERY. IT IS UNKNOWN IF A COUNTER-CLOCKWISE ROTATION OF THE CATHETER WAS CONDUCTED UPON ATTEMPTED REMOVAL OF THE DEVICE OR IF THE BALLOON RETURNED TO AMBIENT PRESSURE; HOWEVER, NEGATIVE PRESSURE WAS MAINTAINED UPON ATTEMPTED REMOVAL OF THE BALLOON CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908581 ↗
• MalfunctionFeb 2, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  AS REPORTED, DURING AN ENDOVASCULAR ANEURYSM REPAIR INVOLVING THE ABDOMINAL AORTA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE BALLOON WAS PREPARED AS INSTRUCTED. ANOTHER MANUFACTURER'S 7-FRENCH SHEATH WAS USED, AND THE BALLOON CATHETER WAS ADVANCED TO THE STENOSED LESION IN THE ABDOMINAL AORTA. THE RENAL ARTERY, BELOW THE AREA OF STENOSIS, WAS REPORTEDLY FULLY CALCIFIED. ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED TO ATTEMPT INFLATION TO FIVE ATMOSPHERES; HOWEVER, THE BALLOON WOULD NOT ACHIEVE NOMINAL PRESSURE. THE BALLOON WAS DEFLATED, AT WHICH POINT BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. 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 18635212 ↗
• MalfunctionJan 16, 2020Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED ON 21JAN2020 NOTING THAT THE TARGET LESION WAS IN THE LEFT ILIAC AND IT WAS 80% OCCLUDED. NO SHEATH WAS UTILIZED WITH THE BALLOON CATHETER. ACCORDING TO THE INITIAL REPORTER THE DEVICE WAS ONLY INFLATED ONE TIME WITH AN UNSPECIFIED INFLATION DEVICE. THE CONTRAST TO SALINE RATIO WAS 1:7. NO BLOOD WAS NOTED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED INSIDE OF A STENT. AFTER THE RUPTURE, THE BALLOON DEVICE WAS REMOVED ALONE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9595711 ↗
• InjuryJan 2, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN IN-STENT RESTENOSIS CASE INVOLVING THE ILIAC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. AN UNKNOWN SHEATH AND INFLATION DEVICE WERE USED IN THE CASE AND ISOVUE CONTRAST WAS USED TO INFLATE THE BALLOON. CALCIFICATION WAS NOT REPORTED; HOWEVER, THE STENOSED AREA WAS REPORTEDLY 100% OCCLUDED. THE DEVICE WAS INFLATED TO EIGHT ATMOSPHERES AT WHICH TIME IT RUPTURED CIRCUMFERENTIALLY. AN UNKNOWN WIRE GUIDE WAS IN THE LUMEN OF THE DEVICE AT THE TIME OF REMOVAL. THE PHYSICIAN WAS ABLE TO REMOVE THE MAJORITY OF THE DEVICE; HOWEVER, ONE OF THE DISTAL MARKERS IS BELIEVED TO HAVE EMBOLIZED IN THE LUNG. THE DECISION WAS MADE TO LEAVE THE MARKER IN PLACE, AS THE PATIENT WAS STABLE. 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: Foreign Body In Patient

  MAUDE report 9539269 ↗
• InjuryJan 14, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ILIAC STENTING PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS USED TO POST-DILATE AN UNKNOWN MANUFACTURER'S STENT. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY (CFA) AND AN IPSILATERAL APPROACH WAS USED TO REACH THE CALCIFIED LESION WITH AN UNSPECIFIED 6 FRENCH COOK PERFORMER SHEATH AND UNKNOWN MANUFACTURER'S 0.035 WIRE GUIDE. BOTH ANGULATION AND VESSEL CALCIFICATION WERE NOTED DURING THE PROCEDURE. THE COMPLAINT DEVICE WAS INFLATED INSIDE THE STENT TO 4 ATMOSPHERES (ATM) WITH 50/50 SALINE AND ISOVIEW CONTRAST MIXTURE WHEN IT RUPTURED "CIRCUMFRENTIALLY". THE COMPLAINT DEVICE DID NOT COME INTO CONTACT WITH THE STENT STRUTS AT THE TIME OF RUPTURE. THE PHYSICIAN WAS UNABLE TO REMOVE THE DEVICE THROUGH THE 6FR SHEATH, AND THEREFORE PULLED THE CATHETER WITH ENOUGH FORCE TO ELONGATE THE DEVICE AND DISSECT THE INNER CATHETER. IT WAS REPORTED THAT APPROXIMATELY 90% OF THE BALLOON CATHETER WAS REMOVED WITH THIS TECHNIQUE. THE 0.035 WIRE GUIDE WAS REPLACED WITH AN UNKNOWN 0.018 WIRE GUIDE AND THE 6FR SHEATH REPLACED WITH AN UNKNOWN 8FR SHEATH AND DILATOR. THE BALLOON WAS UNABLE TO BE REMOVED THROUGH THIS DEVICE, AS W

  Patient problems: No Code Available

  MAUDE report 8245395 ↗
• MalfunctionJul 21, 2017Air Leak; Air Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS LEAKING AIR DURING THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE LEAK WAS DISCOVERED AFTER REACHING THE TARGET LOCATION FOR DEPLOYMENT, WHEN THE BALLOON WAS FIRST PRESSURIZED WITH THE PRESSURE PUMP TO 8 ATM. IT WAS REPORTED THAT THE LEAK WAS ON THE BALLOON ITSELF. THE REPORTER STATED THERE WAS NO CALCIFICATION OF ANGULATION, HOWEVER, THE PATIENT HAD PROMINENT FIBROSIS. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE AIR LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6731688 ↗