Advance G50328Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002503288), received between Mar 31, 2017 and Dec 5, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 11DEC2024. THE BALLOON WAS INFLATED ONE TIME BEFORE RUPTURING CIRCUMFERENTIALLY AT NINE ATMOSPHERES, AT WHICH POINT BLOOD WAS ASPIRATED INTO THE INFLATION DEVICE. THE BALLOON WAS NOT INFLATED WITHIN A STENT. UPON ATTEMPTED REMOVAL OF THE DEVICE, USING A COUNTERCLOCKWISE ROTATION OF THE CATHETER, THE BALLOON MATERIAL SEPARATED FROM THE CATHETER. BECAUSE THE BALLOON HAD RUPTURED, NEGATIVE PRESSURE COULD NOT BE ADEQUATELY ACHIEVED DURING REMOVAL. THE SEPARATED BALLOON MATERIAL WAS SUCCESSFULLY REMOVED AT AN OUTSIDE FACILITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20858403 ↗
• MalfunctionAug 27, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  AS REPORTED, PRIOR TO A LEG CASE WITH STENOSIS A ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED FROM THE PACKAGING AND THE TIP WAS FOUND TO BE FRAYED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459044 ↗
• MalfunctionAug 8, 2019Material Rupture; Material Rupture

  ADDITIONAL INFORMATION WAS RECEIVED 21AUG2019. AS REPORTED, THE TARGET LESION WAS WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY AND WAS 100% OCCLUDED AND SEVERELY CALCIFIED. THERE WAS NO NOTABLE TORTUOSITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874478 ↗
• MalfunctionJun 12, 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 8692587 ↗
• MalfunctionFeb 18, 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 8348435 ↗
• MalfunctionFeb 12, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, A (B)(6) MALE WITH HISTORY OF POPLITEAL ARTERY ENTRAPMENT SYNDROME WAS UNDERGOING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF A CHRONIC TOTAL OCCLUSION IN THE POPLITEAL ARTERY. ACCESS WAS GAINED IN AN IPSELATERAL MANNER FROM THE LEFT FEMORAL ARTERY. THERE WAS NO TORTUOSITY. A WIRE GUIDE FROM UNKNOWN MANUFACTURER ALONG WITH ANOTHER MANUFACTURER'S 5FR SHEATH WERE USED ALONG WITH THE COMPLAINT DEVICE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER. THE COMPLAINT BALLOON WAS INFLATED ONCE, TO 8ATMOSPHERES (ATM) AND TOOK "A VERY LONG TIME" TO DEFLATE. THE INFLATION LASTED 20 SECONDS. ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED FOR THE INFLATION. NEITHER THE TYPE NOR THE RATIO OF CONTRAST TO SALINE WAS PROVIDED. THE COMPLAINT BALLOON WAS WITHDRAWN OVER A WIRE. A COUNTERCLOCKWISE ROTATION WAS NOT USED. AFTER REMOVAL IT WAS ADDITIONALLY NOTED THE DEVICE WAS NOT COMPLETELY DEFLATED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ADVERSE EFFECT TO THE PATIENT. ADDITIONAL PROCEDURES WERE NOT REQUIRED. UPON PRELIMINARY INVESTIGATION ON 06-FEB-2019, IT WAS NOTED THERE WAS A HOLE IN THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER FOUND BETWEEN THE WIRE LUMEN AND BALLO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332048 ↗
• MalfunctionDec 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, AN (B)(6) MALE WAS UNDERGOING A LEFT LEG RUN OFF PROCEDURE OF THE PERONEAL TRUNK WHEN, UPON INITIAL INSERTION, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED CIRCUMFERENTIALLY. THE RUPTURE OCCURRED DURING THE FIRST INFLATION AT 10 ATMOSPHERES (ATM). ANOTHER MANUFACTURER'S INFLATION DEVICE WAS USED. VISIPAQUE CONTRAST TO SALINE WAS USED IN A ONE TO ONE RATIO. THE VESSEL WAS HIGHLY CALCIFIED BUT ONLY SLIGHTLY ANGULATED. AFTER THE RUPTURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED THROUGH A SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON OF THE SAME TYPE. 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 8126274 ↗
• MalfunctionNov 28, 2018Material 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 8110031 ↗
• MalfunctionJun 22, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, DURING AN INTERVENTION OF THE RIGHT POSTERIOR TIBIAL ARTERY, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER PRESENTED WITH A LEAKAGE. WHEN ATTEMPTING TO BRING THE DEVICE UP TO THE RECOMMENDED PRESSURE, THE PHYSICIAN NOTICED IT WOULDN'T INFLATE. UPON THE SECOND AND THIRD ATTEMPTS, THE PHYSICIAN NOTED THAT THERE WAS A LEAK FROM THE DEVICE. THE LEAK OCCURRED OUTSIDE OF THE PATIENT. A NEW ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 7630713 ↗
• MalfunctionMay 8, 2018Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER COULD NOT PASS THROUGH THE LESION AND LATER RUPTURED. IPSILATERAL APPROACH WAS GAINED FROM THE FEMORAL ARTERY TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). TWO OTHER MANUFACTURER'S WIRE GUIDES WERE SUCCESSFULLY ADVANCED PAST THE LESION; HOWEVER, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER COULD NOT PASS. THEREFORE, POBA (PLAIN OLD BALLOON ANGIOPLASTY) WAS PERFORMED BEFORE THE TARGET LESION, BUT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED ON THE SECOND INFLATION AT THE NOMINAL PRESSURE OF 8 (ATM)ATMOSPHERES. ANOTHER MANUFACTURER'S DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7496182 ↗
• MalfunctionApr 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ENDOVASCULAR THERAPY PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED LONGITUDINALLY. THE PHYSICIAN INSERTED THE DEVICE FROM THE RIGHT COMMON FEMORAL ARTERY (CFA) AND ADVANCED IT THROUGH THE SEVERELY CALCIFIED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). HOWEVER, THE BALLOON RUPTURED AT APPROXIMATELY 6 ATMOSPHERES (ATM) PRIOR TO REACHING TO THE NOMINAL INFLATION PRESSURE. OMNIPAQUE CONTRAST WAS USED IN A 1:1 SOLUTION WITH SALINE. SUBSEQUENTLY, THE DEVICE WAS CHANGED WITH ANOTHER MANUFACTURER'S SAME-SIZED DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 7443445 ↗
• MalfunctionMar 31, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT TREATMENT AGAINST CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WAS PERFORMED BY RIGHT COMMON FEMORAL ARTERY APPROACH, USING AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER. WHEN THE PHYSICIAN DILATED THE CTO LESION IN THE SFA, NEAR POPLITEAL ARTERY WITH THE COMPLAINT BALLOON, IT RUPTURED. THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER'S BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DIRECTION OF THE RUPTURE WAS UNKNOWN. THE PATIENT'S CONDITION WAS REPORTED AS RECOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450096 ↗