Advance G52332Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002523323), received between Jul 14, 2017 and Apr 23, 2024 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2024Material Rupture; Material Rupture

  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 19162867 ↗
• MalfunctionApr 11, 2024Difficult to Advance; Difficult to Advance

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS UNABLE TO PASS THROUGH A LESION WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MID-SFA LESION WAS DESCRIBED AS A HIGHLY CALCIFIED, CHRONIC TOTAL OCCLUSION. A CONTRALATERAL APPROACH WAS USED FROM THE "INGUINAL REGION". THE BIFURCATION ANGLE WAS NOT TIGHT, AND THE ANATOMY WAS NOT TORTUOUS; HOWEVER, THE ANATOMY WAS CALCIFIED. ANOTHER MANUFACTURER'S 6-FRENCH SHEATH WAS USED, AS WELL AS ANOTHER MANUFACTURER'S WIRE GUIDE. REPORTEDLY, THE PHYSICIAN WANTED TO CHANGE TO A 0.035-INCH WIRE DURING THE PROCEDURE, BUT COULD NOT DO SO. THE DEVICE WAS FLUSHED BEFORE THE PROCEDURE, PER THE INSTRUCTIONS FOR USE. AFTER THE BALLOON CATHETER (COMPLAINT DEVICE) WAS UNABLE TO CROSS THE SEVERELY CALCIFIED LESION, ANOTHER MANUFACTURER'S 3-MILLIMETER BALLOON CATHETER WAS ABLE TO CROSS THE LESION; HOWEVER, THAT DEVICE FAILED TO DILATE THE LESION. THE USER THEN DECIDED TO DILATE THE LESION AFTER PLACING A STENT; HOWEVER, THE STENT DELIVERY SYSTEM WAS UNABLE TO PASS THROUGH TO THE TARGET SITE. DURING THE PROCEDURE, BLOOD FLOW "STOPPED"; THEREFORE, THE PROCEDURE WAS CONVERTED TO A FEMORAL-TO-POPLITEAL BYPASS AND CO

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reduced Blood Flow

  MAUDE report 19087265 ↗
• MalfunctionMar 6, 2024Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 14MAR2024. THE PROCEDURE INVOLVED AN ARTERIOVENOUS (AV) DIALYSIS SHUNT. THE PATIENT'S ANATOMY WAS STENOSED, AND THE LEFT ARM AV ANASTOMOSIS/RADIAL-CEPHALIC FISTULA WAS HIGHLY OCCLUDED. AN UNSPECIFIED 6-FRENCH SHEATH WAS USED DURING THE PROCEDURE, AS WELL AS AN UNSPECIFIED INFLATION DEVICE. THE BALLOON WAS INFLATED TWO TIMES TO AN UNKNOWN PRESSURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT, AND BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON CATHETER WAS REMOVED BY ITSELF, AND A NEW BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS NOT HOSPITALIZED, AND 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18844477 ↗
• MalfunctionApr 17, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  AS REPORTED, DURING A PROCEDURE TO TREAT PERIPHERAL ARTERIAL OCCLUSIVE DISEASE, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON LEAKED FROM A PINHOLE. ANOTHER MANUFACTURER'S 7-FRENCH SHEATH AND 0.035-INCH WIRE WERE USED DURING THE PROCEDURE. THE BALLOON WAS INFLATED ONE TIME WITHIN A 60% OCCLUDED LESION IN THE KNEE, USING ANOTHER MANUFACTURER'S INFLATION DEVICE; HOWEVER, THE PRESSURE DECREASED UPON REACHING SIX ATMOSPHERES. THE ANATOMY WAS REPORTEDLY NOT TORTUOUS OR CALCIFIED. THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE AS THE BALLOON PRESSURE DECREASED. AFTER THE LEAK OCCURRED, THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE; HOWEVER, NEGATIVE PRESSURE WAS NOT MAINTAINED UPON REMOVAL OF THE DEVICE, AND A COUNTER-CLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED. THE BALLOON WAS REMOVED FROM THE PATIENT BY ITSELF, LEAVING THE WIRE IN PLACE, AND ANOTHER BALLOON 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 DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753872 ↗
• MalfunctionFeb 15, 2023Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY OF A STENOSED LESION IN THE TIBIAL TRUNK, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED UPON THE FIRST INFLATION OF THE DEVICE. A COOK INFLATION DEVICE WAS USED TO INFLATE THE BALLOON, WHICH RUPTURED AT THREE ATMOSPHERES. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS REMOVED THROUGH THE 6-FRENCH COOK ANSEL SHEATH THAT WAS IN PLACE, AND 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 16380745 ↗
• MalfunctionJul 11, 2022Material Separation; Material Separation

  AS REPORTED, WHILE REMOVING THE BALLOON OF A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER FROM THE PATIENT, A PIECE OF THE BALLOON CAME OFF. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 14977113 ↗
• MalfunctionJun 27, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING TREATMENT OF A CALCIFIED LESION WITHIN THE ILIAC ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED UPON THE FIRST INFLATION. ACCESS WAS OBTAINED IN THE FEMORAL ARTERY, AND ANOTHER MANUFACTURER'S 6 FRENCH SHEATH WAS USED. THE DEVICE WAS INFLATED WITH A SYRINGE AND THE INFLATION PRESSURE IS UNKNOWN. THE BALLOON WAS REMOVED BY ITSELF AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14827915 ↗
• MalfunctionAug 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  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 12323805 ↗
• MalfunctionFeb 22, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY OF A STENOSED FISTULA, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE DEVICE WAS ADVANCED TO THE FISTULA AND INFLATED TO 15 ATMOSPHERES WITH AN UNKNOWN INFLATION PUMP, WHEN SUDDENLY THE USER NOTED A LOSS OF RESISTANCE. THE BALLOON WAS REMOVED AND CONTRAST WAS "PLAYED OUTSIDE THE BODY" AND THE BALLOON COULD NOT BE FILLED. ANOTHER 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11361720 ↗
• MalfunctionDec 2, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936007 ↗
• MalfunctionJan 2, 2020Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Patient Involvement

  MAUDE report 9539346 ↗
• MalfunctionSep 12, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED BELOW BURST PRESSURE. ANOTHER MANUFACTURER'S SHEATH WAS USED DURING THE PROCEDURE AS WELL AS ANOTHER MANUFACTURER'S INFLATION DEVICE. THE BALLOON RUPTURED UPON INITIAL INFLATION OF THE DEVICE AND WAS REMOVED BY ITSELF. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9009805 ↗
• MalfunctionJul 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY DURING A LEFT LOWER LIMB "ANGIO" PROCEDURE. THE PHYSICIAN WAS TREATING A SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) WITHOUT ANGULATION. THE COMPLAINT DEVICE WAS INFLATED UP TO THE RATED BURSE PRESSURE (RBP) OF 15 ATMOSPHERES (ATM) USING A NON-COOK INFLATION DEVICE WITH A 70/30 OMNIPAQUE/SALINE CONTRAST MIX. 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. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710589 ↗
• MalfunctionDec 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY AT THE PROXIMAL END OF THE BALLOON. THE INFLATION PRESSURE USED WAS 12 ATMOSPHERE (ATM); THE BALLOON RUPTURED IN THE PATIENT'S FISTULA. 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 7151586 ↗
• MalfunctionJul 27, 2017Hole In Material; Leak/Splash

  THE INFORMATION RECEIVED INDICATED THAT A SMALL HOLE (LEAK) WAS OBSERVED IN THE BALLOON. THE DEVICE WAS DELIVERED TO THE TARGET LESION AND AN ATTEMPT TO INFLATE WAS MADE, BUT THE BALLOON DID NOT INFLATE. THE BALLOON WAS TESTED ON THE BACK TABLE AND A SMALL HOLE (LEAK) WAS OBSERVED. 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 6748359 ↗
• MalfunctionJul 26, 2017Leak/Splash

  THE BALLOON DID NOT INFLATE DURING AN SFA (SUPERFICIAL FEMORAL ARTERY), AND IT WAS NOTED THAT THE CATHETER LOST LIQUID. IT WAS FURTHER CONFIRMED THAT THERE WAS A PINHOLE LEAK IN THE BALLOON. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745501 ↗
• MalfunctionJul 14, 2017Hole In Material

  THE INFORMATION RECEIVED INDICATED THAT A 35LP BALLOON WAS ADEQUATELY FLUSHED AND PLACED THROUGH A SHEATH. DURING THE FIRST ATTEMPT TO INFLATE, THE BALLOON DID NOT FILL UP. A HOLE IN THE BALLOON CATHETER NEAR THE PROXIMAL HUB WAS OBSERVED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER BALLOON. 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 6714857 ↗