Advance G35532Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002355320), received between Jul 12, 2017 and Feb 8, 2023 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Break; Break

  AS REPORTED, DURING AN ANGIOGRAM OF THE LEG, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BECAME STUCK AND SUBSEQUENTLY SEPARATED AFTER REMOVAL FROM THE PATIENT. ACCESS WAS OBTAINED IN THE RIGHT COMMON FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TARGET A 60%-70% OCCLUDED LESION IN THE LEFT MID-SUPERFICIAL FEMORAL ARTERY (SFA). THE ANATOMY WAS TORTUOUS AND RESISTANCE WAS REPORTED UPON ADVANCEMENT OF BOTH THE BALLOON CATHETER AND A COOK SHEATH OVER ANOTHER MANUFACTURER'S 0.035-INCH WIRE GUIDE; HOWEVER, THE DEVICES WERE ABLE TO REACH THE TARGET LESION. THE BALLOON WAS INFLATED TO TEN ATMOSPHERES, USING AN UNKNOWN INFLATION DEVICE, TWO TIMES FOR APPROXIMATELY THREE-TO-FIVE SECONDS EACH TIME. NO ISSUES WERE NOTED DURING INFLATION. ONCE DEFLATED, THE BALLOON WAS ALLOWED TO RETURN TO AMBIENT PRESSURE AND NEGATIVE PRESSURE WAS MAINTAINED; HOWEVER, A COUNTER-CLOCKWISE ROTATION OF THE DEVICE WAS NOT CONDUCTED UPON WITHDRAWAL. UPON REMOVAL OF THE BALLOON, IT BECAME STUCK ON THE WIRE, WITHIN THE SHEATH. THE PHYSICIAN PULLED A "LITTLE MORE" AND THE WIRE, BALLOON CATHETER, AND SHEATH WERE REMOVED FROM THE PATIENT, LOSING ACCESS. AFTER REMOVAL FROM THE PATIENT, THE BALLOON CATHETER S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326688 ↗
• MalfunctionMay 20, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING AN ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INFLATION OF THE BALLOON. THE BALLOON WAS INFLATED WITHIN A HEAVILY CALCIFIED AREA, AND SHARP CALCIFICATION WAS REPORTED. PER THE REPORTER, THE USER BELIEVES THAT THE CALCIUM CAUSED THE BALLOON TO RUPTURE. THE COMPLAINT DEVICE WAS REMOVED AND ANOTHER UNKNOWN BALLOON 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 ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454491 ↗
• MalfunctionMay 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760443 ↗
• MalfunctionNov 19, 2020Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING AN ANGIOPLASTY USING AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER, THE BALLOON LEAKED. THE PHYSICIAN ADVANCED THE BALLOON CATHETER INTO POSITION WITH NO DIFFICULTIES. UPON THE INITIAL INFLATION, THE BALLOON LEAKED INTO THE VESSEL AND FAILED TO HOLD PRESSURE. THERE WAS NO ANGULATION, VESSEL TORTUOSITY, OR VESSEL CALCIFICATION NOTED. THE DEVICE WAS REMOVED AND ANOTHER SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. NO DEVICE SEGMENT REMAINED INSIDE OF THE PATIENT. NO ADDITIONAL PROCEDURES WERE NEEDED AS A RESULT OF THIS OCCURRENCE. NO ADVERSE EFFECTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10870296 ↗
• MalfunctionSep 22, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570211 ↗
• MalfunctionSep 11, 2020Material 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 Consequences Or Impact To Patient

  MAUDE report 10520977 ↗
• InjuryFeb 25, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  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 8366048 ↗
• MalfunctionOct 5, 2018Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7938352 ↗
• InjuryJun 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING STENTING OF A LESION IN THE POPLITEAL SUPERFICIAL FEMORAL ARTERY (SFA), THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND WAS PARTIALLY REMOVED FROM THE PATIENT'S ANATOMY. THE PHYSICIAN ATTEMPTED TO USE A SNARE TO RETRIEVE THE RETAINED PORTION BUT WAS UNSUCCESSFUL. THIS RETAINED PORTION WAS EVENTUALLY PUSHED BELOW THE PROFUNDA AND PERMANENTLY STENTED AGAINST THE WALL OF THE SFA. REPORTEDLY, THE COMPLAINT DEVICE HAD BEEN INFLATED TO FIFTEEN POUNDS PER SQUARE INCH (PSI) IN THE MODERATELY TO SEVERELY CALCIFIED SFA. NO ANGULATION WAS PRESENT. A COOK 7X45 ANSEL SHEATH WAS BEING UTILIZED AND A WIRE GUIDE WAS IN PLACE DURING ATTEMPTED REMOVAL OF THE RETAINED PORTION OF THE COMPLAINT DEVICE. 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; No Code Available

  MAUDE report 7630152 ↗
• MalfunctionFeb 26, 2018Hole In Material; Material Rupture; Hole In Material; Material Rupture

  IT WAS REPORTED THAT DURING A LEFT LOWER EXTREMITY ANGIOGRAM FOR A MID SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS INFLATED AT EIGHT (8) ATMOSPHERE (ATM) AND THOUGHT TO HAVE RUPTURED. THE BALLOON CATHETER WAS REMOVED AND INFLATED OUTSIDE OF THE PATIENT, AND IT WAS OBSERVED THAT THERE WAS A NEEDLE SIZE LEAK PROXIMAL TO THE EDGE OF THE BALLOON CATHETER. IT WAS NOTED THAT THE PATIENT'S VESSELS WERE CALCIFIED. 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 7297317 ↗
• MalfunctionOct 6, 2017Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE ON THE SUPERFICIAL FEMORAL ARTERY (SIDE UNSPECIFIED), THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BALLOON WOULD NOT INFLATE TO NOMINAL PRESSURE AND IT WAS LOSING DYE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED, AND THERE WAS NO ANGULATION. THE BALLOON WAS INJECTED WITH 50/50 CONTRAST/ SALINE, AND THERE WAS NO DIFFICULTY CROSSING ANYTHING WHILE ADVANCING. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT. THE REPORTER POSTULATED THAT THE LEAK COULD NOT HAVE BEEN DUE TO A RUPTURE BECAUSE THE BALLOON NEVER INFLATED TO NOMINAL PRESSURE. 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 Consequences Or Impact To Patient

  MAUDE report 6919503 ↗
• MalfunctionSep 7, 2017Material Rupture; Material Rupture

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A LOWER EXTREMITY ANGIOGRAM. IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS STENTS PLACED THAT HAD RESTENOSED; THEREFORE, A NEW STENT WAS PLACED INSIDE A PRE-EXISTING STENT. WHEN A BALLOON WAS ADVANCED FOR POST DILATATION OF THE NEW STENT IT RUPTURED AT A NOMINAL PRESSURE OF 10ATM. 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 6849533 ↗
• MalfunctionAug 21, 2017Hole In Material; Leak/Splash; Hole In Material; Leak/Splash

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED IN A SUPERFICIAL FEMORAL ARTERY CASE. IT WAS REPORTED THAT THE BALLOON WOULD NOT HOLD PRESSURE. THE BALLOON WAS REMOVED AND IT WAS OBSERVED THAT THE DEVICE HAD A PINHOLE LEAK. 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 6806919 ↗
• MalfunctionAug 2, 2017Hole In Material; Defective Device; Hole In Material; Defective Device

  AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS USED FOR A SUPERFICIAL FEMORAL ARTERY (SFA) PROCEDURE. IT WAS REPORTED THAT THE BALLOON WOULD NOT STAY INFLATED; ONCE THE BALLOON WAS REMOVED, A PINHOLE LEAK WAS DISCOVERED. THERE WAS VESSEL CALCIFICATION NOTED BUT NO ANGULATION. PATIENT OUTCOME WAS NOT REPORTED HOWEVER, THERE WAS NO MEDICAL/SURGICAL INTERVENTION PERFORMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6760980 ↗
• MalfunctionJul 25, 2017Burst Container or Vessel

  DURING AN ANGIOPLASTY AND ATHERECTOMY OF THE RIGHT LEG, THE PHYSICIAN INTRODUCED THE BALLOON IN THE SUPERFICIAL ARTERY. A CSI DEVICE HAD ALREADY BEEN USED AND THE PHYSICIAN WENT TO ANGIOPLASTY. THE PHYSICIAN INFLATED THE BALLOON TO THE BURST RATE, BUT DID NOT EXCEED IT. THE BALLOON WAS INFLATED APPROXIMATELY 30 SECONDS AND THEN IT BURST. THE PROCEDURE WAS COMPLETE AT THIS POINT AND THE DEVICE WAS REMOVED. THE PHYSICIAN FOLLOWED UP WITH AN ANGIOGRAM AND EVERYTHING WAS GOOD. THERE WAS NO HARM TO THE PATIENT AND NOTHING DETACHED INSIDE OF THE PATIENT. THE RUPTURE WAS FOUND TO BE LONGITUDINAL, AND THE PHYSICIAN NOTED THAT THERE WAS SOME CALCIFICATION IN THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6740322 ↗
• MalfunctionJul 21, 2017Hole In Material; Hole In Material

  IT WAS REPORTED THAT DURING PREPARATION FOR A PERIPHERAL ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS NOTED TO HAVE A HOLE IN IT. THE MEDICAL TEAM OPENED AND USED A COMPETITOR DEVICE TO COMPLETE THE PROCEDURE. THE REPORTED EVENT OCCURRED PRIOR TO PATIENT CONTACT THEREFORE, THEREFORE DID NOT RESULT IN ANY ADVERSE EVENT OR INJURY TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6734319 ↗
• MalfunctionJul 17, 2017Inflation Problem; Leak/Splash

  IT WAS REPORTED DURING THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY PROCEDURE FROM RIGHT RETROGRADE PUNCTURE, THE BALLOON WOULD NOT MAINTAIN PRESSURE UNDER INFLATION. THE USER OF THE DEVICE WAS "UNHAPPY WITH THE PERFORMANCE OF THE DEVICE". IT WAS NOTED THAT IMAGING IDENTIFIED LEAKAGE (CONTRAST) FROM THE DEVICE. 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 6719079 ↗
• MalfunctionJul 14, 2017Burst Container or Vessel

  DURING A LEFT LEG ANGIO PROCEDURE, THE BALLOON CATHETER BURST AT 4-6 ATM IN THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S PRODUCT. ACCORDING TO THE INITIAL REPORTER, THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY, NO ADDITIONAL PROCEDURES WERE REQUIRED, AND THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714771 ↗
• MalfunctionJul 13, 2017Leak/Splash; Material Puncture/Hole

  THE INFORMATION RECEIVED INDICATED THAT THE BALLOON WAS NOTED TO BE PUNCTURED DURING THE PROCEDURE AND THEREFORE DID NOT HOLD PRESSURE, RESULTING IN LEAKAGE.A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE AND ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710452 ↗
• MalfunctionJul 12, 2017Inflation Problem

  THE REPORTED INFORMATION INDICATED THAT UPON INFLATING THE BALLOON, THE BALLOON WOULD NOT HOLD PRESSURE AND CONTINUOUSLY DEFLATED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT ASSOCIATED WITH THE ISSUE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708699 ↗
• MalfunctionJul 12, 2017Hole In Material; No Pressure

  WHEN ATTEMPTING TO INFLATE THE BALLOON IT WOULD NOT HOLD PRESSURE. WHEN THE BALLOON WAS OBSERVED A PINHOLE WAS NOTED IN THE BALLOON. NO ADVERSE EVENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6707095 ↗
• MalfunctionJul 12, 2017Detachment Of Device Component

  DURING AN ANGIOGRAM OF THE FEMORAL ARTERY, THE PHYSICIAN PLACED THE STENT AND INFLATED THEN DEFLATED THE BALLOON. UPON REMOVING THE BALLOON IT PARTIALLY DETACHED FROM THE CATHETER AND THEN GOT CAUGHT ON THE SHEATH. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE DEVICE FROM THE PATIENT. THE PHYSICIAN WAS FINISHED WITH THIS PROCEDURE SO NO ADDITIONAL DEVICES WERE REQUIRED. THERE WAS AN UNSPECIFIED AMOUNT OF BLOOD BUT NO TRANSFUSION WAS REQUIRED. NO ADDITIONAL PROCEDURES OR INTERVENTION REQUIRED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6706704 ↗