Advance G52360Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002523606), received between Jun 27, 2016 and Nov 4, 2024 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE BETWEEN THE PORTAL VEIN AND INFERIOR VENA CAVA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER¿S BALLOON LEAKED. THE ANATOMY WAS STENOSED, TORTUOUS, AND/OR CALCIFIED. A 10-FRENCH COOK SHEATH WAS USED DURING THE PROCEDURE. A COOK CONTRAST CATHETER WAS INSERTED INTO ABNORMAL ESOPHAGEAL VARICES AND EMBOLIC GELATIN SPONGE PARTICLES WERE SLOWLY INJECTED. THE COMPLAINT DEVICE WAS THEN ADVANCED OVER A WIRE GUIDE. THE BALLOON WAS INFLATED TO SIX ATMOSPHERES ONE TIME; HOWEVER, THE BALLOON LEAKED, AND BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS REMOVED, AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. THE INITIAL EVALUATION OF THE RETURNED/USED DEVICE, RECEIVED ON 31OCT2024, INDICATES THE BALLOON LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605109 ↗
• InjuryMay 5, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING A FISTULAGRAM INVOLVING AN EIGHTY-TO-NINETY PERCENT OCCLUDED LESION WITHIN THE LEFT UPPER ARM/BASILIC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. ANOTHER MANUFACTURER¿S 6 (B)(6) SHEATH WAS USED WITH THE COMPLAINT DEVICE. THE ANATOMY WAS REPORTEDLY NOT TORTUOUS OR CALCIFIED. AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON THREE TIMES, FOR ONE MINUTE PER INFLATION. UPON THE THIRD INFLATION, THE PHYSICIAN INFLATED THE BALLOON AS HIGH AS THE INFLATION DEVICE WOULD GO (APPROXIMATELY TWENTY-FIVE TO THIRTY ATMOSPHERES), AT WHICH POINT THE BALLOON RUPTURED BOTH LONGITUDINALLY AND CIRCUMFERENTIALLY. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON, SHEATH, AND WIRE WERE REMOVED TOGETHER; HOWEVER, A MINOR CUT-DOWN WAS REQUIRED TO REMOVE THE BALLOON IN ONE PIECE. NO FRAGMENTS SEPARATED FROM THE BALLOON CATHETER OR REMAINED IN THE PATIENT. ONE STITCH WAS PLACED AT THE CUT-DOWN SITE. NO OTHER DILATION WAS REQUIRED TO COMPLETE THE PROCEDURE. UPON RETURN OF THE DEVICE, THE BALLOON MATERIAL WAS RUPTURED AND SEPARATED, WITH THE SEPARATED BALLOON MATERIAL STILL ATTACHED TO THE CA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290964 ↗
• MalfunctionAug 23, 2021Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING AN ILIAC PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE MIX OF CONTRAST TO SALINE USED WAS OMNIPAQUE 50/50. THE DEVICE WAS ADVANCED TO A 70% OCCLUDED RIGHT EXTERNAL ILIAC, WHERE HEAVY CALCIFICATION AND A STENT WERE PRESENT, USING A 6 FRENCH 45 CENTIMETER ANSEL SHEATH. THE DEVICE WAS INFLATED TO BETWEEN 8 AND 11 ATMOSPHERES WHILE IN THE STENT AND BURST. BLOOD WAS NOTED IN THE INFLATION DEVICE FOLLOWING THE RUPTURE. THE BALLOON WAS REMOVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355052 ↗
• InjuryOct 16, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

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

  Patient problems: No Code Available

  MAUDE report 9198700 ↗
• InjuryJul 16, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 NOTING THAT THE REMAINDER OF THE DISTAL PORTION OF THE COMPLAINT DEVICE WAS SUCCESSFULLY RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8795348 ↗
• InjuryFeb 22, 2019Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED, AN (B)(6) MALE WEIGHING (B)(6) WITH MEDICAL HISTORY OF DIABETES (TYPE UNSPECIFIED), UNDERWENT BALLOON ANGIOPLASTY AND STENT PLACEMENT IN THE EXTERNAL ILIAC ARTERY. THE VESSEL WAS TORTUOUS AND HIGHLY CALCIFIED. ANGULATION WAS REPORTED. PRIOR TO THIS PROCEDURE, IT WAS DETERMINED THE PATIENT WOULD REQUIRE AN OPEN BYPASS PROCEDURE. THE STENT (MANUFACTURER UNKNOWN) WAS PROPERLY EXPANDED. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS INFLATED INSIDE THE STENT USING A COOK INFLATION DEVICE. THE COMPLAINT BALLOON WAS QUICKLY INFLATED AND RUPTURED CIRCUMFERENTIALLY AT 8 ATMOSPHERES (ATM). A SLIGHT TINGE OF BLOOD WAS NOTED IN THE INFLATION DEVICE. THE TYPE AND RATIO OF THE INFLATION MEDIUM WAS NOT PROVIDED. THE COMPLAINT BALLOON WAS REMOVED OVER A WIRE AND ALONG WITH THE SHEATH. A PORTION OF THE BALLOON COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S ANATOMY. THE PHYSICIAN WILL REMOVE IT DURING THE OPEN BYPASS PROCEDURE WHICH IS SCHEDULE ON (B)(6) 2019. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8361530 ↗
• MalfunctionDec 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING DILATION OF THE ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. A CONTRALATERAL APPROACH WAS USED, AND WHEN THE DEVICE WAS INFLATED TO NINE (9) BAR, THE BALLOON WAS REPORTED TO BE "CRACKED." REPORTED PRE-EXISTING CONDITIONS INCLUDE ILIAC STENOSIS AND LOWER LIMB ARTERIAL OCCLUSION. ANOTHER MANUFACTURER'S BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. IT HAS NOT BEEN REPORTED THAT A SECTION OF THE DEVICE REMAINED 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT ANATOMY HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8138149 ↗
• InjuryApr 12, 2018Material Rupture; Human Factors Issue; Material Rupture; Human Factors Issue

  IT WAS REPORTED THE 8X60MM ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING A RIGHT UPPER EXTREMITY FISTULAGRAM PROCEDURE FOR ANGIOPLASTY. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED THROUGH A 5FR SHEATH OVER AN 0.35 GLIDE WIRE. THE BALLOON WAS INFLATED 3 TIMES WITHOUT INCIDENT UP TO A MAX PRESSURE OF 18-20 ATMOSPHERES(ATM). IT WAS REPORTED THE PHYSICIAN WAS AWARE THE RATED BURST PRESSURE WAS 11 ATM. THE 4TH AND FINAL TIME THE BALLOON WAS INFLATED TO 18ATM IT RUPTURED CIRCUMFERENTIALLY, LEAVING THREE-QUARTERS OF THE BALLOON AND ONE RADIOPAQUE MARKER INSIDE THE FISTULA AT THE ACCESS SITE. UNSPECIFIED CONTRAST WAS USED AT A 70/30 MIX. REPORTEDLY THERE WAS NO VESSEL ANGULATION OR CALCIFICATION. OF NOTE, PRIOR TO THE PROCEDURE, THE PHYSICIAN NOTED THAT THE FISTULA HAD THROMBOSED PROXIMAL TO THE ACCESS SITE; THEREFORE, HE DECIDED TO PERFORM AN OPEN REVISION TO REMOVE THE BALLOON MATERIAL VERSUS TRYING TO REMOVE IT ENDOVASCULARLY. ALL OF THE BALLOON MATERIAL INCLUDING THE BAND WAS REMOVED WITHOUT INCIDENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; Thrombosis

  MAUDE report 7426829 ↗
• MalfunctionSep 13, 2017Hole In Material; Inflation Problem; Hole In Material; Inflation Problem

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN UNSPECIFIED PROCEDURE. IT WAS REPORTED THAT, THE BALLOON COULD NOT BE FULLY INFLATED, ONLY ONE THIRD OF THE BALLOON WOULD INFLATE. THE BALLOON WAS REMOVED AND IT WAS OBSERVED TO BE LEAKING FROM A PIN HOLE IN THE BALLOON MATERIAL. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 6863040 ↗
• InjuryAug 8, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED DURING A DIALYSIS FISTEL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. IT WAS REPORTED THAT THE BALLOON SNAPPED FROM THE BALLOON PART. THE REMAINING PART OF THE BALLOON WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. A SECTION OF THE DEVICE WAS SUCCESSFULLY RETRIEVED FROM INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6773525 ↗
• InjuryJun 27, 2016Material Rupture; Material Rupture

  THE PHYSICIAN WAS USING THIS PRODUCT TO PERFORM AN AVF FISTULOPLASTY IN THE CEPHALIC VEIN. A 6MM BALLOON HAD BEEN USED INITIALLY AND THEN UPSIZED TO THIS 8MM BALLOON WHICH RUPTURED CIRCUMFERENTIALLY. THE PHYSICIAN PULLED THE SHEATH BACK AND OUT OF THE AVF, THE BALLOON CATHETER REMAINED INSIDE. HE THEN USED A SCALPEL TO MAKE THE ACCESS SITE LARGER TO PULL OUT THE BALLOON CATHETER, AS HE PULLED ON THE BALLOON CATHETER TO REMOVE IT, THE RUPTURED TIP DETACHED AND THE CATHETER CAME OUT. THE PHYSICIAN ENTERED THE AVF WITH FORCEPS AND SECURED THE DETACHED TIP . HE THEN MADE ANOTHER INCISION IN THE FISTULA TO REMOVE THE DETACHED BALLOON SEGMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5752153 ↗