Advance G52338Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002523385), received between Jul 12, 2017 and Nov 1, 2023 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  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 18049942 ↗
• MalfunctionJun 3, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11931617 ↗
• MalfunctionMar 12, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY OF THE POPLITEAL ARTERY, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY ON THE FIRST INFLATION, PRIOR TO REACHING TEN ATMOSPHERES. THE LESION WAS REPORTEDLY 50% OCCLUDED, AND TORTUOSITY AND CALCIFICATION WERE NOT NOTED. AN UNKNOWN 6 FRENCH SHEATH AND INFLATION DEVICE WERE USED DURING THE PROCEDURE, AS WELL AS A 50/50 MIXTURE OF OMNIPAQUE CONTRAST AND SALINE. THE BALLOON AND DELIVERY SYSTEM WERE REMOVED OVER AN UNKNOWN WIRE GUIDE. BLOOD WAS NOT OBSERVED IN THE INFLATION DEVICE, AND THE BALLOON WAS NOT INFLATED WITHIN A STENT PRIOR TO RUPTURE. 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 9823637 ↗
• MalfunctionFeb 18, 2020Material Rupture; Material Rupture

  ADDITIONAL INFORMATION RECEIVED 17 MAR 2020. AS REPORTED, THE PROCEDURE PERFORMED WAS AN ANGIOPLASTY AT THE ANASTOMOSIS OF A PERIPHERAL ARTERY BYPASS VEIN GRAFT. THE PATIENT PRESENTED WITH ANGULATION AND TORTUOSITY AT THE BIFURCATION AND AN OVER 50% OCCLUDED TARGET LESION. ANOTHER MANUFACTURER'S 6 FRENCH SHEATH, AN UNKNOWN INFLATION DEVICE, AND 50/50 OMNIPAQUE CONTRAST WERE USED DURING THE PROCEDURE. A WIRE GUIDE WAS IN PLACE AND NEGATIVE PRESSURE MAINTAINED DURING BALLOON REMOVAL. THE BALLOON WAS NOT INFLATED INSIDE A STENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9720461 ↗
• MalfunctionJan 20, 2020Material 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 Consequences Or Impact To Patient

  MAUDE report 9606946 ↗
• MalfunctionDec 4, 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 9410394 ↗
• InjuryNov 1, 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

  MAUDE report 9266017 ↗
• MalfunctionAug 22, 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 8920983 ↗
• InjuryJul 2, 2019Fluid/Blood Leak; Fluid/Blood Leak

  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 8754933 ↗
• MalfunctionJun 26, 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 8735897 ↗
• InjurySep 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) CASE ON AN UNSPECIFIED DATE, UPON APPROACH OF THE LESION AND DURING INFLATION THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER CIRCUMFERENTIALLY RUPTURED. THIS OCCURRED PRIOR TO THE NOMINAL DIAMETER BEING REACHED. GIVEN THE TIGHT STENOSIS, THE DISTAL REMNANT OF THE BALLOON COULD NOT BE RETRIEVED AND THEREFORE A STENT WAS DEPLOYED TO SUPPORT PATENCY OF THE VESSEL AS WELL AS PREVENTING DISTAL EMBOLI COMPLICATIONS. ANOTHER MANUFACTURER'S BALLOON WAS USED TO POST-DILATE THE STENT. NO INFORMATION WAS PROVIDED REGARDING CALCIFICATION OR TORTUOSITY OF THE VESSEL. STENT SIZE WAS NOT PROVIDED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7882601 ↗
• MalfunctionApr 12, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED VASCULAR PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY AFTER INFLATION TO 10 ATMOSPHERES (ATM). DURING THE PROCEDURE, ACCESS WAS GAINED FROM THE LEFT COMMON FEMORAL ARTERY (CFA) CONTRALATERALLY USING ANOTHER MANUFACTURER'S GUIDING SHEATH. THE 0.035 INCH WIRE GUIDE WAS ADVANCED THROUGH THE CALCIFIED, STENOSED TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). NEXT, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION WHERE IT RUPTURED UPON INFLATION. ANOTHER MANUFACTURER'S BALLOON DEVICE WAS FINALLY 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426773 ↗
• MalfunctionJul 25, 2017Material Rupture; Material Rupture

  IT IS ALLEGED THAT AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WAS BEING USED FOR AN ENDOSCOPIC THIRD VENTRICULOSTOMY PROCEDURE WHEN THE BALLOON RUPTURED. IT WAS REPORTED THAT A WIRE GUIDE PASSED THROUGH THE LESION SUCCESSFULLY, AS DID THE BALLOON CATHETER, AS THE PATIENT'S ANATOMY WAS SAID TO HAVE SOME CALCIFICATIONS, BUT NOTHING SEVERE. THE COMPLAINANT CLAIMS THAT AS THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, HOWEVER, IT FAILED. THE BALLOON CATHETER WAS REMOVED, AND ALLEGEDLY THE BALLOON DEVICE EXHIBITED A LONGITUDINAL RUPTURE. IT WAS REPORTED THAT ANOTHER MANUFACTURER'S BALLOON 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 6741993 ↗
• MalfunctionJul 14, 2017Fluid/Blood Leak

  THE BALLOON DID NOT INFLATE DURING AN SFA (SUPERFICIAL FEMORAL ARTERY) PROCEDURE AND AFTER CHECKING INJECTING LIQUID OUT OF THE PATIENT, IT WAS NOTED THAT THE CATHETER LOST LIQUID. IT WAS FURTHER CONFIRMED THAT THERE WAS A PINHOLE LEAK IN THE BALLOON. 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 6714975 ↗
• MalfunctionJul 13, 2017Leak/Splash

  THE REPORTED INFORMATION INDICATED THAT WHEN USING AN ADVANCE 35 LP BALLOON FOR DILATION THE PRESSURE DIDN'T GO HIGHER THAN 6 ATM AND SEEMED TO LEAK. THE BALLOON WENT IN NORMALLY THROUGH 6 F INTRODUCER. A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT, NO ADDITIONAL PROCEDURES WERE REQUIRED AND THE PATIENT DID NOT EXPERIENCE AND ADVERSE EFFECTS RELATED TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6710999 ↗
• MalfunctionJul 12, 2017Material Rupture

  THE BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708782 ↗
• MalfunctionJul 12, 2017Burst Container or Vessel

  THE INFORMATION REPORTED INDICATED THAT A BALLOON BURST OCCURRED AT 15 ATMOSPHERES DURING POST-DILATION OF A STENT WITH A PTA5-35-80-5-4.0 BALLOON. THE TARGET LESION WAS THE RIGHT SUPERFICIAL FEMORAL ARTERY; APPROACH WAS ANTEGRADE THROUGH THE RIGHT COMMON FEMORAL ARTERY. THE LESION WAS DESCRIBED AS A CHRONIC TOTAL OCCLUSION. THE LESION WAS PRE-DILATED AND A PTX STENT WAS PLACED. THE LESION WAS POST-DILATED WITH A PTA5-35-80-5-4.0 BALLOON UP TO 15 ATMOSPHERES WHEN IT RUPTURED. A SECOND BALLOON WAS ADVANCED TO THE LESION FOR POST DILATION AND THAT RUPTURED AT 18 ATMOSPHERES, THE STENT WAS SUFFICIENTLY POST-DILATED WITH A THIRD BALLOON AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705581 ↗