Advance G52352Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002523521), received between Apr 22, 2015 and Aug 15, 2023 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Material 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 17549709 ↗
• MalfunctionOct 29, 2021Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  ADDITIONAL INFORMATION RECEIVED 11JAN2022. AN INFLATION DEVICE WAS USED, AND THE BALLOON WAS INFLATED 1 TO 2 TIMES, 30 SECONDS EACH TIME. A 1 TO 1 RATIO OF CONTRACT TO SALINE WAS USED. AFTER THE BALLOON BURST, IT WAS REMOVED THROUGH AN UNKNOWN MANUFACTURER'S 5 FRENCH SHEATH. THE LESION WAS LOCATED AT THE BILIARY TRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719159 ↗
• MalfunctionSep 14, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN EVT A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS FOUND TO HAVE RUPTURED. THE CATHETER WAS INSERTED THROUGH THE RFA, AND ADVANCED TO THE RIGHT EIA, BOTH OF WHICH WERE NOTED TO BE CALCIFIED, WHEN THE USER EXPERIENCED BACKFLOW OF BLOOD INTO THE INDEFLATOR DURING THE FIRST BALLOON INFLATION TO 10 ATM, WITH A 1:! MIXTURE OF CONTRAST AND SALINE. THE USER THEN CHECKED THE DEVICE AND NOTICED THE BALLOON HAD RUPTURED. THE BALLOON WAS THEN REMOVED AND ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PORTION OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THIS DID NOT RESULT IN ADDITIONAL PROCEDURES, OR PROLONGED HOSPITALIZATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530828 ↗
• MalfunctionAug 7, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN ANGIOPLASTY OF THE SFA A ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS IN USE, BUT AS IT WAS BEING INFLATED IT BURST. THE USER THEN REMOVED THE BALLOON OVER THE WIRE AND THROUGH THE SHEATH WITHOUT ISSUE. NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THIS EVENT DID NOT RESULT IN ADDITIONAL PROCEDURES OR PROLONGED HOSPITALIZATION. NO ADVERSE EFFECTS TO THE PATIENT OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF/WHEN IT IS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10378972 ↗
• InjuryJul 1, 2019Material 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 Code Available

  MAUDE report 8749745 ↗
• MalfunctionJan 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING INFLATION. AN ENDOVASCULAR THERAPY PROCEDURE (EVT) WAS PERFORMED FROM THE FEMORAL ARTERY TO TREAT A CALCIFIED LESION IN THE ILIAC ARTERY. THE PHYSICIAN ATTEMPTED TO INFLATE THE COMPLAINT DEVICE IN THE LESION FOR THE FIRST TIME BUT THE BALLOON WAS RUPTURED DURING THE INFLATION. THE PATIENT'S ANATOMY WAS DESCRIBED AS TORTUOUS (DEGREE UNKNOWN) WITH SEVERE CALCIFICATIONS. THE PHYSICIAN USED ANOTHER MANUFACTURER'S BALLOON INSTEAD TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT ADVERSE EFFECTS. ADDITIONALLY, IT WAS REPORTED ANOTHER MANUFACTURER'S WIRE GUIDE, SHEATH, AND INFLATION DEVICE WERE USED DURING THE PROCEDURE. INFLATION PRESSURE WAS UNKNOWN. DIRECTION OF RUPTURE WAS UNKNOWN. TYPE AND RATIO OF CONTRAST USED WAS UNKNOWN. THE COMPLAINT DEVICE WAS NOT INFLATED INSIDE A STENT AND WAS REMOVED COMPLETELY FROM THE PATIENT'S ANATOMY. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8228529 ↗
• MalfunctionNov 5, 2018Material Rupture

  BALLOON ANGIOPLASTY WAS BEING PERFORMED ON LEFT ARM AV FISTULA WITH TIGHT STENOSIS. A .035 GLIDEWIRE WAS ADVANCED PAST THE LESION. BALLOON WAS ADVANCED OVER THE WIRE BY PHYSICIAN. BALLOON WAS SLOWLY INFLATED OVER 2 MINUTES TO BURST PRESSURE. BALLOON RUPTURED CIRCUMFERENTIALLY AND FRACTURED PART OF BALLOON HAD TO BE RETRIEVED VIA CUT-DOWN PROCEDURE. MANUFACTURER RESPONSE FOR BALLOON, COOK (B)(4) (PER SITE REPORTER): I WILL SEND INFO FROM THE CONVERSATIONS BETWEEN THE RADIOLOGIC PRACTITIONER ASSISTANT AND COOK.

  Patient problems: Stenosis

  MAUDE report 8037541 ↗
• InjuryNov 5, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  PLEASE SEE H10 FOR ADDITIONAL INFORMATION CONCERNING THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 8037528 ↗
• MalfunctionJun 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A FISTULA PROCEDURE IN THE MILD TO MODERATELY CALCIFIED ILIAC ARTERY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY IN THE PATIENT'S ANATOMY. NOMINAL PRESSURE WAS USED. THERE WAS NO ANGULATION PRESENT IN THE ARTERY. A MIX OF 30 PERCENT OMNIPAQUE CONTRAST TO 70 PERCENT SALINE WAS USED DURING THE PROCEDURE. ANOTHER BALLOON CATHETER 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. THE COMPLAINT DEVICE WAS DISCARDED AT THE FACILITY AND IS, THEREFORE, NOT AVAILABLE FOR INVESTIGATION BY THE MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649869 ↗
• MalfunctionMay 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A RIGHT ILIAC ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AFTER TWO TO THREE ATMOSPHERES (ATM) OF PRESSURE WAS APPLIED. THE BALLOON SUSTAINED A CIRCUMFERENTIAL TEAR CAUSING THE DISTAL PORTION TO INVERT. THE COMPLAINT DEVICE WAS ABLE TO BE SUCCESSFULLY REMOVED WITHOUT ADVERSE EFFECT TO THE PATIENT. ACCORDING TO THE INITIAL REPORTER, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S ANATOMY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7554576 ↗
• MalfunctionMar 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A RIGHT ILIAC INTERVENTION, A 8 MILLIMETER (MM) DIAMETER BY 140 MM LENGTH ZILVER FLEX STENT WAS PLACED AND POST DILATATION WAS BEING PERFORMED WITH THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. THE BALLOON CATHETER RUPTURED DURING THE THIRD INFLATION AT A PRESSURE OF 6 ATMOSPHERE (ATM). THE RUPTURED DEVICE WAS REMOVED AND ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE PATIENT'S VESSELS WERE CALCIFIED. NO ADDITIONAL INTERVENTION WAS REQUIRED. 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 7346107 ↗
• MalfunctionNov 29, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DILATION OF A LEFT SUPERFICIAL FEMORAL ARTERY (SFA) LESION WITH CALCIFICATION WAS INITIALLY PERFORMED USING A 4 MILLIMETER (MM) BALLOON CATHETER. THE PHYSICIAN SWITCHED TO A LARGER SIZE BALLOON, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, AND SUCCESSFULLY DILATED THE LESION FURTHER BY APPLYING NOMINAL PRESSURE. A SECOND DILATION AT NOMINAL PRESSURE (8 ATMOSPHERE (ATM)) WAS PERFORMED, AND THE BALLOON CATHETER RUPTURED. 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 7067238 ↗
• InjuryOct 26, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A DIALYSIS ACCESS FISTULOGRAM PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY WHILE AT AN INFLATION PRESSURE OF LESS THAN OR EQUAL TO 12, AND THEN SEPARATED PRIOR TO REMOVAL. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ABLE TO BE COMPLETELY REMOVED FROM INSIDE OF THE PATIENT. AN ADDITIONAL PROCEDURE WAS COMPLETED TO PLACE ANOTHER MANUFACTURER'S STENT AS THERE WAS A RUPTURE IN THE PATIENT'S LEFT BASILIC VEIN. IT IS UNKNOWN IF THE COMPLAINT DEVICE CAUSED OR CONTRIBUTED TO THE RUPTURED VEIN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Perforation of Vessels

  MAUDE report 6982296 ↗
• InjurySep 6, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN AN ANGIOPLASTY. IT WAS REPORTED THAT, THE BALLOON RUPTURED IN TWO PIECES AT A MAXIMUM PRESSURE OF 12ATM. ONE PIECE OF THE RUPTURED BALLOON REMAINED IN THE PATIENT. A "LASSO" WAS USED TO RETRIEVE THE PIECE OF BALLOON. THE PATIENT DID NOT REQUIRE ANY OTHER 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: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6846031 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR A PROCEDURE WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT THE COMPLAINT DEVICE WAS ADVANCED TO THE TARGET LESION IN CTO OVER ANOTHER MANUFACTURER'S WIRE GUIDE BY IPSILATERAL APPROACH. THE COMPLAINANT CONTINUES THAT IT WAS DURING THE PRE-DILATION OF THE CTO LESION IN THE ILIAC ARTERY THAT THE BALLOON RUPTURED. ANOTHER "35 LP" BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6732033 ↗
• MalfunctionJul 18, 2017Sticking; Stretched

  THE PRODUCT WAS BEING USED DURING A FISTULAGRAM WITH A GLIDE WIRE AND WHEN THE PHYSICIAN TRIED TO PULL THE BALLOON OUT, IT GOT STUCK IN THE SHEATH. THE SHEATH HAD TO BE REMOVED TO GET THE BALLOON OUT. UPON FURTHER REVIEW OF THE DEVICE, IT WAS NOTED THAT THE DEVICE WAS STRETCHED OUT. 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 6722718 ↗
• MalfunctionJul 17, 2017Material Rupture; Device Operates Differently Than Expected

  A PATIENT WITH PAD (PERIPHERAL ARTERY DISEASE) UNDERWENT PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) AGAINST THE ISR (IN-STENT RESTENOSIS) WITH ANOTHER MANUFACTURER'S DEVICE; IT WAS PLACED IN THE RIGHT POPLITEAL ARTERY AND WAS PERFORMED BY IPSILATERAL ANTEGRADE APPROACH FROM THE RIGHT FEMORAL ARTERY. AFTER THE TARGET ISR WAS DILATED TWICE WITH THE COMPLAINT BALLOON BY APPLYING 8 ATM PRESSURE, THE PHYSICIAN ATTEMPTED TO DILATE THE ISR FURTHER BY APPLYING 12 ATM PRESSURE TO THE BALLOON. HOWEVER, ALTHOUGH 12 ATM WAS THE RBP (RATED BURST PRESSURE) OF THIS PRODUCT, THE BALLOON RUPTURED ONCE IT REACHED 12 ATM. THE DEVICE WAS REPLACED WITH ANOTHER 35LP BALLOON OF A DIFFERENT LENGTH WHICH WAS INFLATED TO 12 ATM PRESSURE WITHOUT PROBLEMS. THE PHYSICIAN NOTED THAT THIS EVENT WAS POSSIBLY AFFECTED BY SEVERE CALCIFICATION OF THE LESION AND THE FACT THAT THE DEVICE WAS USED TO ISR. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6717806 ↗
• MalfunctionApr 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A DIALYSIS PROCEDURE USING AN ADVANCE 35 LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED UPON INFLATION. THE BALLOON WAS PAST 12 ATM (RATE OF BURST). THE DIRECTION OF THE BALLOON RUPTURE WAS UNKNOWN. THE BALLOON WAS VERY NEAR A STENT EDGE; THROUGH A STENT. THE LESION WAS IN THE FOREARM WITH NO ANGULATION OR VESSEL CALCIFICATION NOTED. THE TYPE OF CONTRAST THAT WAS USED WAS A MIX OF CONTRAST AND SALINE, VISPAQUE 50/50. THE PROCEDURE WAS COMPLETED USING THE BALLOON OF ANOTHER (UNSPECIFIED) MANUFACTURER. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS OR PROCEDURES AS A RESULT OF THIS EVENT . ADDITIONALLY, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511090 ↗
• MalfunctionApr 20, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANTEGRADE APPROACH WITH RIGHT FEMORAL PUNCTURE - ANGIOPLASTY TO RIGHT SFA, USING AN ADVANCE 35 LOW PROFILE BALLOON CATHETER, THE BALLOON RUPTURED DURING THE 3RD INFLATION. THE TARGETED LESION WAS LOCATED IN THE MID TO UPPER THIRD OF THE SFA. THERE WAS VESSEL CALCIFICATION NOTED BUT NO ANGULATION. INFLATION PRESSURE USED WAS REPORTED TO BE 10ATM. TYPE OF CONTRAST USED WAS A MIX OF 50/50 CONTRAST TO SALINE. ADDITIONALLY, IT WAS REPORTED THAT THE BALLOON RUPTURED CIRCUMFERENTIALLY. THE RUPTURED BALLOON COULD NOT BE WITHDRAWN HOWEVER FROM THE INTRODUCER THEREFORE THE INTRODUCER AND DAMAGED BALLOON HAD TO BE REMOVED OVER THE GUIDEWIRE. ANOTHER INTRODUCER WAS PLACED AND THE PROCEDURE WAS COMPLETED. IT WAS ALSO REPORTED THE OPERATOR SAID THE CASE WAS "TECHNICALLY DIFFICULT". NO SECTION OF THE DEVICE REMAINED INSIDE OF THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6507107 ↗
• MalfunctionMar 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A FISTULAGRAM PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AT 6 ATM. THE FISTULA WAS IN THE FOREARM AND THERE WAS ANGULATION. THE REPORTER STATED THERE WAS NO CALCIFICATION BUT A STENT WAS IN PLACE. THE COOK REPRESENTATIVE STATED THAT THE BURST APPEARED TO BE FROM A PINHOLE. THE CONTRAST BEING USED AS 50% VISIPAQUE AND 50% HEPARINIZED SALINE. THERE WAS NO UNINTENDED SECTION OF THE DEVICE LEFT INSIDE OF THE PATIENT'S BODY. THERE WAS NO ADDITIONAL PROCEDURES DONE. THE PATIENT WAS UNHARMED. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6422181 ↗
• MalfunctionMar 10, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ANOTHER MANUFACTURER'S STENTS WERE PLACED IN THE RIGHT AND LEFT ILIAC ARTERIES BY LEFT COMMON FEMORAL ARTERY APPROACH. AFTER STENT DEPLOYMENT, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED FOR POST-DILATION HOWEVER, THE BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE REPORTER STATED THAT THE DEVICE WOULD NOT BE RETURNED DUE TO INFECTIOUS DISEASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6394858 ↗
• InjuryApr 22, 2015Material Separation

  A PELVIC ANGIOGRAM WAS BEING PERFORMED ON AN (B)(6) MALE PATIENT, WHO HAD HEAVILY CALCIFIED ILIACS AND A HISTORY OF VASCULAR DISEASE. A .035" 7 X 40 X 80 BALLOON WAS ADVANCED OVER THE WIRE AND INFLATED TO NOMINAL PRESSURE. THE BALLOON PERFORATED AND WAS WITHDRAWN OFF THE WIRE. AT THIS TIME, THEY NOTICED THE BALLOON WAS COMPLETELY TORN AND THE BALLOON CATHETER TIP WAS INSIDE THE PATIENT ON THE WIRE AS THEY COULD SEE THE MARKER. ARTERY FORCEPS WERE USED TO TRY AND REMOVE THE WIRE AND CATHETER. AT THIS STAGE, THE CATHETER BROKE IN HALF AGAIN. ARTERY FORCEPS WERE THEN USED TO REMOVE THE REST OF THE PRODUCT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCES.

  Patient problems: Foreign body, removal of

  MAUDE report 4730750 ↗