Advance G30958Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10827002309583), received between Sep 12, 2017 and Oct 4, 2024 — classified as 4 injuries, 18 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. 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.

• MalfunctionOct 4, 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 20367967 ↗
• MalfunctionApr 24, 2024Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING AN INTERVENTION WITHIN A CHRONIC TOTAL OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED. THE ANATOMY WAS CALCIFIED. ACCESS WAS OBTAINED IN THE LEFT POSTERIOR TIBIAL ARTERY, AND THE LESION WAS CROSSED WITH A COOK CATHETER AND UNSPECIFIED "STIFF GLIDE" WIRE. A COOK 5-FRENCH ANSEL SHEATH WAS USED DURING THE PROCEDURE. AFTER AN UNKNOWN "1.5" LASER WAS USED OVER A COOK WIRE GUIDE, THE COMPLAINT DEVICE WAS USED. AN UNSPECIFIED INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TWO TIMES FOR TEN SECONDS; HOWEVER, THE BALLOON RUPTURED UPON THE SECOND INFLATION, AT FOUR ATMOSPHERES. BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON CATHETER WAS REMOVED OVER THE WIRE GUIDE, AND ANOTHER DEVICE OF THE SAME TYPE WAS THEN OPENED. THE NEW BALLOON WAS INFLATED TWO TIMES TO EIGHT ATMOSPHERES, FOLLOWED BY ANOTHER MANUFACTURER'S CUTTING BALLOON, AND THE PROCEDURE WAS COMPLETED AFTER PLACEMENT OF TWO COOK STENTS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19173952 ↗
• MalfunctionApr 22, 2024Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED AFTER AN ATHERECTOMY OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE PATIENT HAD CALCIFIED ANATOMY AND THE LESION WAS FIFTY PERCENT OCCLUDED. AN UNSPECIFIED ANSEL SHEATH WAS UTILIZED DURING THE PROCEDURE. THE BALLOON RUPTURED UPON ITS SECOND INFLATION WITH AN UNSPECIFIED INFLATION DEVICE AT EIGHT ATMOSPHERES AND THE INFLATION WAS HELD FOR ONE MINUTE POST CSI. THE BALLOON WAS REMOVED OVER THE UNSPECIFIED HYDRO ST WIRE. BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE BALLOON WAS NOT INFLATED INSIDE OF A STENT PRIOR TO RUPTURE. THE PROCEDURE WAS COMPLETED BY OPENING A SECOND UNSPECIFIED BALLOON AND THEN STENTED. 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 OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154098 ↗
• MalfunctionMar 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED DURING AN ANTEGRADE PEDAL ACCESS THROUGH AN 80% OCCLUDED SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON FIRST INFLATION AT 4 ATM USING AN INFLATION DEVICE. A "4FR/5FR SHEATH" WAS UTILIZED AND BLOOD WAS NOTED IN THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED INSIDE OF A STENT PRIOR TO THE RUPTURE. THE BALLOON WAS REMOVED AND IT WAS REPORTED THAT THERE WAS NOT AN UNINTENDED SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486099 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY AT EIGHT ATMOSPHERES. A COOK SHEATH AND COOK INFLATION DEVICE WERE USED DURING THE PROCEDURE. THE BALLOON WAS INFLATED ONE TIME FOR TEN SECONDS WITHIN THE MID-SFA, WHICH WAS 100% OCCLUDED AND VERY CALCIFIED. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON WAS REMOVED INTACT. DURING THE SAME PROCEDURE, ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER ALSO RUPTURED (COOK REFERENCE # (B)(4)). A THIRD BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13773015 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY WITHIN THE SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY AT EIGHT ATMOSPHERES. A COOK SHEATH AND COOK INFLATION DEVICE WERE USED DURING THE PROCEDURE. THE BALLOON WAS INFLATED ONE TIME FOR TEN SECONDS WITHIN THE MID-SFA, WHICH WAS 100% OCCLUDED AND VERY CALCIFIED. BLOOD WAS NOTED IN THE INFLATION DEVICE AT THE TIME OF RUPTURE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. THE BALLOON WAS REMOVED INTACT. DURING THE SAME PROCEDURE, ANOTHER ADVANCE 18 LP LOW PROFILE BALLOON CATHETER ALSO RUPTURED (COOK REFERENCE # (B)(4)). A THIRD BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13772974 ↗
• MalfunctionMar 3, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTION INVOLVING THE EXTERNAL ILIAC AND SUPERFICIAL FEMORAL ARTERIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. FOLLOWING PLACEMENT OF ANOTHER MANUFACTURER'S ATHERECTOMY DEVICE, THE DEVICE RUPTURED ON THE FIRST INFLATION TO EIGHT ATMOSPHERES FOR PRE-DILITATION PRIOR TO STENT PLACEMENT IN THE EXTERNAL ILIAC AND SUPERFICIAL FEMORAL ARTERIES. THE VESSELS WERE MILDLY CALCIFIED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S 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. ADDITIONAL EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659824 ↗
• InjuryDec 9, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 12970543 ↗
• MalfunctionMay 17, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831295 ↗
• MalfunctionDec 7, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

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

  MAUDE report 10959562 ↗
• InjuryNov 12, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 10828186 ↗
• MalfunctionFeb 14, 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 9712713 ↗
• MalfunctionFeb 14, 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 9712613 ↗
• MalfunctionJan 10, 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 9574749 ↗
• MalfunctionOct 3, 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 Consequences Or Impact To Patient

  MAUDE report 9152308 ↗
• InjurySep 5, 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 8964456 ↗
• MalfunctionMay 31, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED, PLEASE SEE H10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8659635 ↗
• InjuryJan 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: Foreign Body In Patient; No Code Available

  MAUDE report 8253275 ↗
• MalfunctionNov 14, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, AN (B)(6) MALE WEIGHING (B)(6) WAS UNDERGOING A LEFT POPLITEAL INTERVENTION PROCEDURE. ON INITIAL INFLATION, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVELOPED A PINHOLE LEAK AT THE PROXIMAL END. THE COMPLAINT DEVICE WAS INFLATED TO 8 ATMOSPHERES (ATM) WITH A MIX OF UNSPECIFIED CONTRAST TO SALINE IN A 4:10 RATIO USING A COOK SPHERE INFLATION DEVICE. LENGTH OF INFLATION TIME WAS NOT KNOWN. THERE WAS NO ANGULATION BUT SOME CALCIFICATION OF THE TARGET VESSEL. THE COMPLAINT DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED SUCCESSFULLY 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 Consequences Or Impact To Patient

  MAUDE report 8068905 ↗
• MalfunctionSep 12, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE BALLOON PORTION OF THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER BURST WHEN BEING INFLATED INSIDE THE ARTERY DURING AN UNSPECIFIED PROCEDURE. ACCORDING TO THE COMPLAINANT, A PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S ANATOMY. NEITHER ADDITIONAL PROCEDURES NOR ADVERSE EFFECTS OCCURRED AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, THE COMPLAINANT REPORTED NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7869740 ↗
• MalfunctionJul 10, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER BURST DURING A LEFT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY. THE DEVICE WAS INFLATED TO 6 ATMOSPHERES OF PRESSURE WITH AN "ISODUSE 50/50" SOLUTION WHEN IT EXPERIENCED THE RUPTURE. IT IS UNCLEAR IF THE RUPTURE WAS LONGITUDINAL OR CIRCUMFERENTIAL. THERE WAS NO ANGULATION, HOWEVER, HEAVY CALCIFICATION WAS NOTED. AFTER THE RUPTURE, THE DEVICE WAS REMOVED AND ANOTHER WAS USED SUCCESSFULLY. 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 7673630 ↗
• MalfunctionSep 12, 2017Material Rupture; Material Rupture

  AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED IN A LOWER EXTREMITY ANGIOGRAM. IT WAS REPORTED, DURING THE SECOND INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED INSIDE A PREVIOUSLY PLACED ZILVER FLEX STENT. PRIOR TO BALLOON INFLATION, LASER ATHERECTOMY OF IN-STENT RESTENOSIS WAS PERFORMED. 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 6860089 ↗