Advance G30946Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002309460), received between Jun 11, 2018 and Aug 8, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionAug 8, 2024Break; Break

  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 19938716 ↗
• MalfunctionJan 31, 2024Break; Material Rupture; Material Separation; Break; Material Rupture; Material Separation

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER'S BALLOON RUPTURED UPON THE SECOND INFLATION, AT ELEVEN ATMOSPHERES. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18616573 ↗
• MalfunctionMar 10, 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: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521265 ↗
• MalfunctionOct 25, 2021Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING A BELOW-THE-KNEE INTERVENTION WITH ANGIOPLASTY, A HOLE WAS FOUND IN AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER. THE DEVICE WAS INSERTED VIA ANOTHER MANUFACTURER'S 6FR SHEATH FOR INTERVENTION IN THE 10% OCCLUDED TIBIAL ARTERY. THE PATIENT'S ANATOMY WAS MILDLY CALCIFIED BUT NOT ANGULATED OR TORTUOUS. THE DEVICE WAS INFLATED FOR ONE MINUTE WITH CONTRAST USING A COOK INFLATION DEVICE, BUT THE DEVICE WAS NOT VERY VISIBLE UNDER FLUOROSCOPY. THE DEVICE WAS REMOVED FROM THE PATIENT THROUGH THE SHEATH, AND A SMALL HOLE WAS OBSERVED IN THE BALLOON WHEN THE DEVICE WAS REINFLATED OUTSIDE OF THE PATIENT. ANOTHER 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 12688984 ↗
• MalfunctionApr 7, 2021Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  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 11629332 ↗
• MalfunctionAug 17, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413433 ↗
• MalfunctionMar 3, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE OF THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AT SIX ATMOSPHERES. A COOK 6 FRENCH, 45 CENTIMETER ANSEL SHEATH AND HYDRO ST WIRE WERE USED DURING THE PROCEDURE. AN UNKNOWN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON WITH A 50/50 RATIO OF HEPARINIZED SALINE TO VISIPAQUE CONTRAST. THE DEVICE RUPTURED AT SIX ATMOSPHERES UPON THE FIRST INFLATION WITHIN THE 85% OCCLUDED LESION. THE PATIENT REPORTEDLY HAD MILDLY CALCIFIED ANATOMY; HOWEVER, ANGULATION AND TORTUOSITY WERE NOT REPORTED. THE BALLOON WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE FOLLOWING RUPTURE. THE BALLOON WAS REMOVED OVER THE WIRE GUIDE AND ANOTHER BALLOON OF THE SAME SIZE 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 Consequences Or Impact To Patient

  MAUDE report 9780578 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING A RUNOFF PROCEDURE OF THE RIGHT DISTAL SUPERFICIAL FEMORAL AND PROXIMAL POPLITEAL ARTERIES, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE PATIENT, WITH A HISTORY OF PERIPHERAL ARTERY DISEASE, HAD EXTREMELY CALCIFIED PLAQUE IN THE AREA, MAKING IT DIFFICULT TO CROSS THE COMPLETELY OCCLUDED LESION. TORTUOSITY AND ANGULATION WERE NOT REPORTED. A COOK 35LP BALLOON DID NOT CROSS THE LESION; THEREFORE, THE COMPLAINT DEVICE WAS USED. THE COMPLAINT DEVICE CROSSED THE LESION; HOWEVER, THE BALLOON RUPTURED ON CALCIFIED PLAQUE UPON THE SECOND INFLATION, USING UP TO NOMINAL PRESSURE. IT IS UNKNOWN WHAT THE CONTRAST TO SALINE RATIO USED TO INFLATE THE BALLOON WAS. BLOOD WAS NOTED IN THE UNKNOWN INFLATION DEVICE AND THE COMPLAINT DEVICE WAS REMOVED OVER AN UNKNOWN WIRE, LEAVING THE COOK 7 FRENCH SHEATH IN PLACE. THE FIRST COOK 35LP BALLOON WAS THEN USED BUT WAS AGAIN UNABLE TO CROSS THE CALCIFIED LESION. A THIRD UNKNOWN BALLOON, OF A DIFFERENT SIZE, WAS USED TO TREAT AN AREA PROXIMAL TO THE LESION. THE USER THEN DECIDED TO ACCEPT THE RESULTS AND THE PROCEDURE WAS CONCLUDED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9746015 ↗
• MalfunctionAug 30, 2019Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION WAS RECEIVED 08OCT2019. AS REPORTED, THE DEVICE WAS USED THROUGH A 6FR COOK SHEATH. THE BALLOON WAS PURGED OF AIR PRIOR TO INSERTION INTO THE PATIENT, AND WAS INCOMPLETELY INFLATED AT 8 ATMOSPHERES. THE PATIENT REPORTEDLY HAD ANGULATION, VESSEL TORTUOSITY, AND APPROXIMATELY 70 PERCENT VESSEL CALCIFICATION RELATIVE TO THE PROCEDURE. NO FURTHER 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 8951393 ↗
• MalfunctionAug 19, 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 Known Impact Or Consequence To Patient

  MAUDE report 8907840 ↗
• MalfunctionJun 11, 2018Fluid/Blood Leak; Hole In Material; Fluid/Blood Leak; Hole In Material

  IT WAS REPORTED, DURING A FISTULAGRAM PROCEDURE, THE BALLOON OF THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS FOUND TO HAVE A HOLE IN IT. THIS WAS DISCOVERED WHEN THE BALLOON WAS INFLATED AND CONTRAST WAS INJECTED. THE CONTRAST LEAKED OUT OF THE BALLOON. THE COMPLAINANT DENIED ANY SCARRING, CALCIFICATION, OR TORTUOSITY OF THE PATIENT'S ANATOMY. THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER. 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 7587878 ↗