Advance G52358Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002523583), received between Aug 19, 2016 and Jan 12, 2023 — classified as 1 injury, 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2023Material Puncture/Hole; Material Puncture/Hole

  AS REPORTED, DURING A RIGHT LOWER EXTREMITY ANGIOPLASTY WITH POSSIBLE STENT PLACEMENT, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DEFLATED. A STENT HAD BEEN PREVIOUSLY PLACED IN THE LEFT ILIAC ARTERY FOR ILIAC OCCLUSION. THE PATIENT PRESENTED WITH SMALL VESSEL DISEASE AND OCCLUSION OF THE RIGHT ILIAC ARTERY. THE COMPLAINT DEVICE WAS ADVANCED THROUGH ANOTHER MANUFACTURER'S SHORT SHEATH TO THE BIFURCATION AND WAS INFLATED AT LEAST TO NOMINAL PRESSURE, ADJACENT TO THE PRE-EXISTING STENT, WITHIN THE COMPLETELY-OCCLUDED LESION. IT IS BELIEVED THAT THE BALLOON BECAME CAUGHT ON THE STRUT OF THE UNKNOWN STENT AND THE BALLOON DEFLATED. THE ANATOMY WAS NOT TORTUOUS OR CALCIFIED. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE. THE BALLOON WAS INTACT UPON REMOVAL FROM THE PATIENT. A NEW 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 16146816 ↗
• MalfunctionJun 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 10138595 ↗
• InjurySep 18, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A LEFT COMMON FEMORAL ARTERY ENDARTERECTOMY PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY AND HAD TO BE SURGICALLY REMOVED. THE MALE PATIENT WITH PAST MEDICAL HISTORY WHICH INCLUDED DIABETES (TYPE UNSPECIFIED), PERIPHERAL VASCULAR DISEASE, AND HYPERTENSION UNDERWENT A THROMBOLYSIS PROCEDURE PRIOR TO THE ENDARTERECTOMY PROCEDURE. THIS WAS ACCOMPLISHED BY PLACING A SHEATH (SIZE AND MANUFACTURER NOT SPECIFIED) IN THE RIGHT GROIN AND INTRODUCING TISSUE PLASMINOGEN ACTIVATOR (TPA) INTO THE CLOTTED ARTERY AND ALLOWING IT TO REMAIN OVERNIGHT. THE SHEATH WAS LEFT IN PLACE AND THE ENDARTERECTOMY WAS PERFORMED THROUGH IT THE FOLLOWING DAY. THE DISTAL BYPASS WAS OPEN BUT THE COMMON FEMORAL ARTERY WAS DISEASED. THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS TO BE PLACED UP AN OVER FOR PROXIMAL CONTROL OF BLEEDING. THE LEFT COMMON FEMORAL ARTERY WAS EXPOSED AND THE BALLOON POSITIONED, THEN INFLATED TO 4 ATMOSPHERES (ATM) UNTIL THE PULSE WAS NO LONGER FELT. THE COMMON FEMORAL ARTERY WAS THEN OPENED AND GOOD CONTROL OF BLEEDING WAS ACHIEVED USING THE BALLOON. THEN PHYSICIAN NOTICED A LEAK OF THE BALLOON BECAUSE THERE WAS BLOOD PRE

  Patient problems: No Code Available

  MAUDE report 7886212 ↗
• MalfunctionMay 10, 2018Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING A LEFT UPPER EXTREMITY FISTULOGRAM WITH POSSIBLE INTERVENTION PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST WHEN IT WAS INFLATED TO BURST PRESSURE, 11 ATMOSPHERES (ATM) OVER AN 0.35 WIRE. UPON REMOVING THE COMPLAINT DEVICE OVER THE WIRE, THE BALLOON FRACTURED. THE PATIENT DID NOT RETAIN ANY BALLOON FRAGMENTS, AS IT WAS REMOVED IN IT'S ENTIRETY WITH THE SHEATH. MANUAL PRESSURE WAS HELD AND VASCULAR ACCESS WAS OBTAINED AGAIN. THE PROCEDURE CONTINUED WITH A NEW BALLOON DEVICE, WIRE AND SHEATH. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7503193 ↗
• MalfunctionApr 20, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A CROSSOVER OF THE HEAVILY CALCIFIED COMMON ILIAC ARTERY PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER BURST. NO SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER. 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 7446980 ↗
• MalfunctionJul 28, 2017Material Rupture

  EVT(ENDOVASCULAR TREATMENT) OF CIA (COMMON ILIAC ARTERY) BY IPSILATERAL RETROGRADE APPROACH FROM CFA (COMMON FEMORAL ARTERY) WAS PERFORMED. THE CIA LESION WAS PRE DILATED WITH A 0.014 INCH BALLOON, AND THEN ANOTHER MANUFACTURER'S STENT WAS PLACED THERE. AFTER THAT, POST DILATION WAS PERFORMED WITH THE COMPLAINT PRODUCT. THE PHYSICIAN NOTED THAT THE LESION WAS SEVERELY CALCIFIED AND THE BALLOON RUPTURED WHEN ONLY 3-4 ATM PRESSURE WAS APPLIED. IT WAS REPLACED WITH AN ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6749820 ↗
• MalfunctionJan 17, 2017Material Rupture; Material Rupture

  THIS COMPLAINT WAS REPORTED TO CUSTOMER SERVICE BY A FOREIGN DISTRIBUTOR. IT WAS REPORTED THE LOW PROFILE BALLOON CATHETER DEVICE WAS USED DURING A STENT PLACEMENT PROCEDURE TO TREAT THE STENOSED ILIAC ARTERY. REPORTEDLY AN IPSILATERAL APPROACH FROM THE GROIN WAS USED AND AFTER PRE-DILATION WITH THE BALLOON DEVICE ANOTHER MANUFACTURER'S STENT WAS PLACED. IT IS ALLEGED THE PTA5 BALLOON RUPTURED DURING POST-DILATION ATTEMPTS ((B)(4); MEDWATCH# 1820334-2017-00049). ANOTHER PTA5-BALLON WAS USED INSTEAD WHICH IS ALLEGED TO HAVE ALSO RUPTURED AFTER BEING INFLATED FOR BALLOONING SEVERAL TIMES. ((B)(4); MEDWATCH# 1820334-2017-00050) ANOTHER MANUFACTURER¿S DEVICE WAS USED TO PERFORM POST-DILATION AND COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6256692 ↗
• MalfunctionAug 19, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A POST-DILATION PROCEDURE, WITH APPROACH FROM THE LEFT COMMON FEMORAL ARTERY (CFA), A CATHETER BALLOON WAS INFLATED FOR POST DILATION AFTER STENT DEPLOYMENT, TO TREAT CHRONIC TOTAL OCCLUSION (CTO) IN THE EXTERNAL ILIAC ARTERY (EIA). THE BALLOON REPORTEDLY RUPTURED AT NOMINAL PRESSURE. ANOTHER BALLOON WITH THE SAME SPECIFICATIONS WAS USED INSTEAD, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5888293 ↗