Advance G50324Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10827002503240), received between Apr 13, 2018 and Jul 27, 2022 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED, DURING A BELOW-THE-KNEE ANGIOPLASTY PROCEDURE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER'S BALLOON WOULD NOT INFLATE DUE TO A LEAK FROM THE PROXIMAL END OF THE BALLOON. 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 15113947 ↗
• MalfunctionDec 7, 2021Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12950931 ↗
• MalfunctionMay 7, 2021Material 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11790008 ↗
• MalfunctionSep 14, 2020Inflation Problem; Inflation Problem

  AS REPORTED, DURING A BALLOON ANGIOPLASTY OF THE POPLITEAL AND POSTERIOR TIBIAL ARTERIES, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WOULD NOT FULLY INFLATE AND A RESTRICTION WAS OBSERVED IN THE MIDDLE OF THE BALLOON. THE USER REPORTED THAT TWO AREAS OF THE BALLOON WOULD NOT INFLATE, AND A "KNOT" WAS OBSERVED IN THE MIDDLE OF THE BALLOON UPON REMOVAL OF THE DEVICE. ANOTHER BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530817 ↗
• MalfunctionFeb 3, 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 9659578 ↗
• MalfunctionJun 15, 2018Material Rupture

  IT WAS REPORTED THAT DURING THE ANGIOPLASTY PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS INFLATED, THE BALLOON RUPTURED. THE BALLOON WAS RETRIEVED FROM THE BODY AND IT WAS NOTED THAT THERE WAS A LEAKAGE OF CONTRAST MEDIA FROM THE BALLOON MATERIAL. 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 7605381 ↗
• MalfunctionJun 14, 2018Split; Physical Resistance

  THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED OVER THE WIRE GUIDE AFTER THE WIRE GUIDE PASSED THROUGH THE TARGET LESION. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCEMENT. RESISTANCE WAS ALSO FELT WHEN REMOVING THE COMPLAINT DEVICE FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THERE WAS A SPLIT IN THE BALLOON ON THE COMPLAINT DEVICE. 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 7602421 ↗
• MalfunctionJun 13, 2018Inflation Problem; Material Rupture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LOW PROFILE BALLOON CATHETER WAS INFLATED, THE BALLOON RUPTURED. 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 7595687 ↗
• MalfunctionJun 5, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED AT AN INFLATION PRESSURE OF 8 ATMOSPHERES (ATM). THE COMPLAINT DEVICE WAS ADVANCED FROM THE FEMORAL ARTERY TO TREAT A SEVERELY CALCIFIED LESION NEAR THE POPLITEAL ARTERY WHEN THE EVENT OCCURRED. THERE WAS NO ANGULATION REPORTED. ANOTHER ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. COMPLAINANT HAD NO INFORMATION REGARDING DIRECTION OF RUPTURE: LONGITUDINAL OR CIRCUMFERENTIAL. COMPLAINANT HAD NO INFORMATION REGARDING TYPE OF CONTRAST USED AND/OR MIX WITH SALINE. 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 7570386 ↗
• MalfunctionApr 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR THERAPY PROCEDURE VIA THE FEMORAL APPROACH, THE BALLOON OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. PER THE INITIAL REPORTER, WHEN THE BALLOON REACHED THE SEVERELY CALCIFIED LESION, IT WAS INFLATED TO 10 ATMOSPHERES (ATM). APPROXIMATELY 100 SECONDS AFTER THE START OF INFLATION THE RUPTURE OCCURRED. IT IS NOT KNOWN IF THE BALLOON RUPTURED LONGITUDINALLY OR CIRCUMFERENTIALLY. CONTRAST USED WAS VISIPAQUE IN A 1:1 RATION WITH SALINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER BALLOON DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430299 ↗