Advance G35527Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002355276), received between Jun 7, 2017 and Aug 29, 2023 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Material Puncture/Hole; Material Rupture; Material Puncture/Hole; Material Rupture

  AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED INSIDE THE PATIENT. A COOK ANSEL 6 X 45 CM SHEATH WAS USED DURING THE PROCEDURE. THE ANATOMY WAS CALCIFIED AND THE LESION WAS 95% OCCLUDED. AN INFLATION DEVICE WAS USED TO INFLATE THE BALLOON TO 8 ATMOSPHERES AND THE BALLOON BURST ON THE FIRST INFLATION. JUST THE BALLOON CATHETER WAS REMOVED AND REPLACED WITH A DIFFERENT SIZED BALLOON CATHETER OF THE SAME TYPE TO COMPLETE THE PROCEDURE SUCCESSFULLY. BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE BALLOON WAS NOT INFLATED INSIDE OF A STENT PRIOR TO THE RUPTURE. THE PATIENT IS REPORTEDLY DOING "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646142 ↗
• MalfunctionSep 30, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554614 ↗
• MalfunctionApr 2, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING A PROCEDURE INVOLVING AN OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED WITHIN A HEAVILY CALCIFIED LESION AT TEN ATMOSPHERES. A COOK INFLATION DEVICE AND A 70/30 RATIO OF SALINE TO CONTRAST WERE USED TO INFLATE THE BALLOON TWICE. EACH INFLATION WAS FOR EIGHT SECONDS. THE BALLOON REPORTEDLY RUPTURED COMPLETELY FROM THE SHAFT OF THE DEVICE UPON THE SECOND INFLATION. THE DEVICE WAS NOT REMOVED FROM THE BODY BETWEEN INFLATIONS AND WAS NOT INFLATED WITHIN A STENT. BLOOD WAS NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE BALLOON WAS REMOVED BY ITSELF, AND A COOK 5X20 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 Consequences Or Impact To Patient

  MAUDE report 9917041 ↗
• MalfunctionNov 20, 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 9348442 ↗
• MalfunctionMar 6, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WOULD NOT MAINTAIN PRESSURE ABOVE 4 ATMOSPHERES. THIS WAS OBSERVED WHILE PERFORMING PRE-DILATION OF THE LEFT SFA/POPLITEAL. ANOTHER MANUFACTURER'S GUIDE WIRE WAS USED ALONG WITH THE COMPLAINT DEVICE. THE COMPLAINT DEVICE WAS REMOVED AND PRE-INFLATION WAS NOT RE-ATTEMPTED. THE LESION WAS STENTED AND POST-DILATION WAS PERFORMED WITH A DIFFERENT SIZE BALLOON. THERE WAS NO HARM TO THE PATIENT. UPON RETURN AND INVESTIGATION OF THE DEVICE, HOWEVER, A PINHOLE WAS FOUND. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394663 ↗
• MalfunctionJul 12, 2017Material Rupture

  DURING A LEFT LEG ANGIO PROCEDURE THE BALLOON CATHETER BURST AT 12 ATM IN THE SUPERFICIAL FEMORAL ARTERY. THE PROCEDURE WAS COMPLETED USING A COMPETITOR'S PRODUCT. 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 6706150 ↗
• InjuryJun 7, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOGRAM PROCEDURE USING AN ADVANCE 35 LOW PROFILE BALLOON CATHETER, THE BALLOON BROKE OFF INSIDE A PATIENT'S BODY. THE MIX OF CONTRAST TO SALINE WAS 50/50. THE LESION WAS LOCATED IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). NO ANGULATION OF THE VESSEL WAS NOTED HOWEVER, THE VESSEL WAS SAID TO BE VERY CALCIFIED. THE BALLOON GOT CAUGHT ON CALCIUM AND BROKE OFF FROM THE DELIVERY SYSTEM. THE INFLATION PRESSURE AND THE DIRECTION OF THE BALLOON RUPTURE WERE BOTH UNKNOWN. A WIRE GUIDE WAS IN PLACE DURING ATTEMPTED REMOVAL. BOTH PARTS OF THE BROKEN DEVICE CAME OUT ON THE WIRE AND NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. NO FURTHER PROCEDURES WERE NECESSARY." NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THERE WAS NO REPORTED ADVERSE EFFECTS ON THE PATENT DUE TO THIS PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6618750 ↗