Advance G50338Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002503387), received between Aug 3, 2016 and Oct 26, 2021 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698452 ↗
• MalfunctionOct 26, 2021Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698435 ↗
• InjuryApr 7, 2020Material Separation; Material Separation

  AS REPORTED, DURING AN ANGIOPLASTY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BALLOON TIP SEPARATED FROM THE CATHETER WHILE INSIDE THE PATIENT. THE USER ATTEMPTED, UNSUCCESSFULLY, TO REMOVE THE SEPARATED PORTION OF THE DEVICE. THE SEPARATED PORTION WAS THEN STENTED TO THE WALL OF THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT'S ANATOMY WAS REPORTEDLY CALCIFIED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 9933177 ↗
• MalfunctionJan 2, 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 9540090 ↗
• MalfunctionNov 20, 2019Material Rupture; Material Rupture

  AS REPORTED, DURING AN ENDOVASCULAR THERAPY PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS GAINED IN THE FEMORAL ARTERY AND A CONTRALATERAL APPROACH WAS USED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. THE COMPLAINT DEVICE WAS ADVANCED TO THE LESION AND THE USER BEGAN TO INFLATE THE BALLOON, WHICH RUPTURED AT 12 ATMOSPHERES. IT IS UNKNOWN IF THE BALLOON RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY. THE DEVICE WAS INFLATED OUTSIDE OF A STENT. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349460 ↗
• MalfunctionMay 24, 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 8640865 ↗
• MalfunctionFeb 11, 2019Material Puncture/Hole; 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 Consequences Or Impact To Patient

  MAUDE report 8327838 ↗
• MalfunctionFeb 6, 2019Material Puncture/Hole; 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 Consequences Or Impact To Patient

  MAUDE report 8310335 ↗
• MalfunctionFeb 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED, THE PHYSICIAN WHO INITIALLY INFORMED COOK OF THIS OCCURRENCE RETURNED A DIFFERENT DEVICE WHICH WAS USED WITHOUT ANY PROBLEMS. THE ACTUAL COMPLAINT DEVICE THAT PRESENTED WITH THE REPORTED FAILURE WAS NOT RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305922 ↗
• MalfunctionJun 15, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE WIRE GUIDE WAS PASSED THROUGH THE LESION AND THE LOW PROFILE BALLOON CATHETER WAS INFLATED, THE BALLOON RUPTURED LONGITUDINALLY. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605424 ↗
• MalfunctionJun 14, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE RIGHT "BA" FOR A STENOSED LESION IN THE CFA (COMMON FEMORAL ARTERY) TO PERFORM A "POBA". IT WAS DIFFICULT TO REACH THE LESION DUE TO SEVERE CALCIFICATION IN THE ILIAC ARTERY. THE USER THEN ATTEMPTED TO INFLATE THE BALLOON AS IT WAS PASSED THROUGH THE LESION, BUT THE BALLOON RUPTURED LONGITUDINALLY AT APPROXIMATELY 4 ATM (ATMOSPHERES). THE DEVICE WAS REPLACED WITH ANOTHER BALLOON AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7601620 ↗
• MalfunctionJun 13, 2018Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY) FOR A CALCIFIED LESION IN THE SFA (SUPERFICIAL FEMORAL ARTERY). THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED FROM THE BRACHIAL ARTERY, AND THE BALLOON RUPTURED BEFORE APPLYING 8 ATM (ATMOSPHERES) AT THE TARGET CALCIFIED LESION. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7596675 ↗
• MalfunctionJun 13, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY, WHEN THE LOW PROFILE BALLOON CATHETER WAS USED, THE BALLOON RUPTURED LONGITUDINALLY. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED AND ANOTHER DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7595884 ↗
• MalfunctionJun 12, 2018Inflation Problem

  THE COMPLAINANT REPORTED THAT THE PATIENT UNDERWENT TREATMENT OF CTP, AND CTO (CHRONIC TOTAL OCCLUSION), APPROXIMATELY 25CM IN LENGTH, WAS OBSERVED FROM THE BIFURCATION OF THE SFA (SUPERFICIAL FEMORAL ARTERY). THERE WAS SEVERE CALCIFICATION. THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED CONTRALATERALLY FOR THE CTO IN THE SFA. AFTER THE BALLOON WAS INFLATED AT THE VALUE OF THE RATED BURST PRESSURE TO TREAT THE LESION NEAR THE ENTRANCE OF THE SFA, IT RUPTURED DURING DEFLATION DUE TO SEVERE CALCIFICATION. ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE PROCEDURE, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7591749 ↗
• MalfunctionJun 12, 2018Material Rupture

  IT WAS REPORTED THAT ACCESS WAS GAINED FROM THE RIGHT FA (FEMORAL ARTERY) FOR CROSSOVER APPROACH. THE PHYSICIAN ADVANCED THE WIRE GUIDE TO THE DESIRED LESION AND THEN ATTEMPTED TO DILATE WITH ANOTHER MANUFACTURER'S BALLOON. THE PHYSICIAN THEN ATTEMPTED TO INFLATE THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BY APPLYING 12-14 ATM (ATMOSPHERES), BUT IT RUPTURED. IT WAS FURTHER NOTED THAT THE PATIENT'S LESION WAS PARTIALLY CALCIFIED. ANOTHER MANUFACTURER'S DEVICE WAS USED FOR THE "EVT" PROCEDURE, AND THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7591580 ↗
• MalfunctionFeb 21, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING ENDOVASCULAR TREATMENT (EVT), UPON INFLATING THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER AFTER ADVANCING PAST THE LESION, THE PHYSICIAN NOTICED THAT CONTRAST MEDIA WAS LEAKING FROM THE SHAFT. ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCESS WAS GAINED VIA RADIAL APPROACH. 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 7285068 ↗
• InjuryAug 30, 2017Deflation Problem; Material Separation; Deflation Problem; Material Separation

  AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED IN A BRACHIAL ACCESS PROCEDURE. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE. A NEEDLE WAS INSERTED IN THE GROIN TO PUNCTURE THE BALLOON WHICH WAS LOCATED IN THE DISTAL SFA. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6831460 ↗
• MalfunctionJul 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED FOR A PLAIN OLD BALLOON ANGIOPLASTY (POBA) PROCEDURE. THE PROCEDURE WAS PERFORMED AGAINST STENOSIS IN LEFT POPLITEAL ARTERY BY CONTRALATERAL APPROACH FROM RIGHT FEMORAL ARTERY. AFTER THE TARGET LESION WAS DILATED WITH THE COMPLAINT DEVICE SEVERAL TIMES REPEATEDLY, THE PHYSICIAN ATTEMPTED TO DILATE THE LESION FURTHER BY APPLYING14 ATM PRESSURE TO THE BALLOON. ALTHOUGH 14 ATM WAS LOWER THAN ITS DEFINED RATED BURST PRESSURE OF 16 ATM, THE BALLOON RUPTURED. ALTHOUGH THE BALLOON RUPTURED, THE LESION SEEMED TO HAVE BEEN SUFFICIENTLY DILATED. THE PHYSICIAN RETRIEVED THE CATHETER, CONDUCTED THE ANGIOGRAPHY, AND ENDED THE PROCEDURE. THERE WAS NO FRAGMENT OF THE BALLOON LEFT INSIDE OF THE PATIENT. THE PHYSICIAN STATED THAT THE LESION MAY HAVE BEEN STIFF AND HARD SINCE SOME CALCIFICATIONS WERE OBSERVED. IT WAS PRESUMED THAT THE DIRECTION OF THE RUPTURE WAS LONGITUDINAL, HOWEVER, THIS IS NOT CONFIRMED. IT WAS REPORTED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6730958 ↗
• MalfunctionAug 3, 2016Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PTA PROCEDURE OF A PATIENT WITH A LESION THAT WAS MILDLY CALCIFIED, THE BALLOON RUPTURED. THE DEVICE WAS ADVANCED FROM THE RIGHT GROIN TO THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH A 5FR GUIDING SHEATH AND A WIRE GUIDE, BOTH FROM OTHER MANUFACTURER'S. DURING BALLOON INFLATION UP TO 16 ATMOSPHERIC PRESSURE (ATM) IN THE LESION, THE BALLOON RUPTURED PRIOR TO REACHING TO 16 ATM. BALLOONS FROM TWO DIFFERENT MANUFACTURER'S WERE USED AS REPLACEMENTS TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION 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 5844104 ↗