Advance G52337Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002523378), received between Jul 26, 2017 and Nov 30, 2017 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2017Kinked; Material Rupture; Material Separation; Kinked; Material Rupture; Material Separation

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY FOR A SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE BALLOON OF THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AT 10 ATMOSPHERE (ATM). A COOK MEDICAL 180 CENTIMETER GUIDE WIRE AND ANOTHER MANUFACTURER'S 5 FR GAUGE SHEATH WERE USED DURING THE ANGIOPLASTY. THE BALLOON CATHETER WAS DEFLATED, AND PARTIALLY RETRIEVED USING AN ANACONDA SNARE OVER THE 180 CENTIMETER GUIDE WIRE BEING UTILIZED. FLUOROSCOPY WAS USED TO VISUALIZE THE REMAINING TIP OF THE DELIVERY CATHETER AND TOP HALF OF THE RUPTURED BALLOON, WHICH WERE THEN ABLE TO BE SUCCESSFULLY REMOVED FROM THE PATIENT'S VESSEL USING THE ANACONDA SNARE. REMOVAL WAS NOTED TO BE DIFFICULT, AND SNARING RESULTED IN A KINK AT THE TIP OF THE DETACHED CATHETER SHAFT. THE PATIENT'S VESSELS WERE HEAVILY CALCIFIED; HOWEVER, THE CUSTOMER NOTED THAT THE CALCIFICATION HAD NOT CAUSED ANY ISSUES PREVIOUSLY DURING THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7072560 ↗
• MalfunctionNov 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PERIPHERAL ANGIOPLASTY, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON INFLATION AT THE LESION SITE. ACCESS TO THE CHRONIC TOTAL OCCLUSION (CTO) LESION WAS GAINED FROM THE FEMORAL ARTERY, AND AN INFLATION PRESSURE OF FIFTEEN (15) ATMOSPHERE (ATM) WAS UTILIZED. THE PATIENT WAS NOTED TO HAVE VESSEL CALCIFICATION; NO ANGULATION WAS PRESENT. ANOTHER ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS UTILIZED 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 Known Impact Or Consequence To Patient

  MAUDE report 7050406 ↗
• MalfunctionJul 28, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED TO TREAT AN OCCLUDED SUPERFICIAL FEMORAL ARTERY WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT THE DEVICE WAS BEING INFLATED WITHIN AN EXTENSIVE AMOUNT OF CALCIFICATION. THE PRESSURE AT WHICH THE DEVICE WAS INFLATED AT THE TIME OF RUPTURE IS UNKNOWN, AS WELL AS THE DIRECTION OF THE RUPTURE. ALLEGEDLY, ANOTHER DEVICE OF THE SAME KIND WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED REGARDING THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6752050 ↗
• MalfunctionJul 26, 2017Material Rupture

  THE DEVICE WAS USED FOR ENDOVASCULAR THERAPY. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA); THE APPROACH WAS ANTEGRADE THROUGH THE RIGHT COMMON FEMORAL ARTERY. THE LESION WAS DESCRIBED AS A CHRONIC TOTAL OCCLUSION. THE RIGHT SFA LESION WAS PRE-DILATED WITH A 0.014 INCH BALLOON TO PLACE PTX STENT(S). THE PTA5-35-80-5-2.0 BALLOON RUPTURED AT 18 ATM (ATMOSPHERES) AFTER REPLACING A RUPTURED PTA5-35-80-5-4.0 BALLOON. THIS BALLOON WAS REPLACED WITH ANOTHER PTA5-35-80-5-2.0 BALLOON THAT ALSO RUPTURED. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE PTA5-35-80-5-2.0 SINCE THE STENT WAS SUFFICIENTLY POST-DILATED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6745254 ↗