Advance G50313Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10827002503134), received between Jul 12, 2017 and Sep 21, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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.

• MalfunctionSep 21, 2021Material Rupture; Material Rupture

  THERE ARE IS NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509536 ↗
• MalfunctionAug 9, 2021Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED DURING AN UNSPECIFIED PROCEDURE INVOLVING A CALCIFIED LESION WITHIN THE SUPERFICIAL FEMORAL ARTERY. FEMORAL ACCESS WAS OBTAINED AND ANOTHER MANUFACTURER'S SHEATH AND UNKNOWN INFLATION DEVICE WERE USED DURING THE PROCEDURE. THE BALLOON RUPTURED UPON THE FIRST INFLATION. THE BALLOON WAS REMOVED BY ITSELF AND ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12295307 ↗
• MalfunctionApr 1, 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 11601730 ↗
• MalfunctionDec 17, 2020Material Rupture; Material Rupture

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11031524 ↗
• MalfunctionMar 28, 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 8460049 ↗
• MalfunctionJun 14, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS ADVANCED PAST THE LESION. THE BALLOON RUPTURED WHEN THE USER INFLATED IT AT NOMINAL PRESSURE. ANOTHER BALLOON CATHETER THAT WAS DIFFERENT IN LENGTH WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7602112 ↗
• MalfunctionJun 12, 2018Hole In Material; Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER HAD RUPTURED DURING USE. ACCESS HAD BEEN GAINED THROUGH THE RIGHT FEMORAL ARTERY BY IPSILATERAL ANTEGRADE APPROACH. THE BALLOON WAS ADVANCED TO THE TARGET LESION AND INFLATED TO 4 ATM (ATMOSPHERES) FOR PRE-DILATION WHEN THE ISSUE OCCURRED. IT WAS LATER REPORTED THAT THE BALLOON HAD A PINHOLE RATHER THAN A FULL TEAR. THE PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7591855 ↗
• MalfunctionMay 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  AN UNUSED, UNOPENED REPRESENTATIVE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR INVESTIGATION OF AN EVENT PREVIOUSLY REPORTED UNDER REPORT REFERENCE NUMBER (B)(4). UPON EXAMINATION, THE REPRESENTATIVE DEVICE WAS FOUND TO HAVE A LEAK. THE DEVICE NEVER MADE PATIENT CONTACT; THEREFORE, NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7502932 ↗
• MalfunctionFeb 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING TREATMENT OF A RESTENOSIS LESION OF THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA) (STENT HAD BEEN PREVIOUSLY PLACED), THE THROMBUS MOVED TO THE POPLITEAL ARTERY. THROMBUS ASPIRATION WAS PERFORMED, HOWEVER IT WAS UNSUCCESSFUL. THE PHYSICIAN ATTEMPTED TO UTILIZE THE ADVANCE 14 LP LOW PROFILE BALLOON CATHETER TO PRESS THE THROMBUS AGAINST THE POPLITEAL ARTERIAL WALL WHILE INFLATING TO PRESSURE OF EIGHT (8) ATMOSPHERE (ATM); HOWEVER, THE BALLOON RUPTURED. ANOTHER COOK MEDICAL 14 LP BALLOON CATHETER OF A DIFFERENT SIZE (2X40 CENTIMETER LENGTH) WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE PATIENT'S ARTERIES WERE CALCIFIED, AND ANGULATION IN THE POPLITEAL ARTERY WAS PRESENT AS THE THROMBUS WAS LOCATED AT THE TRIFURCATION. 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 7236923 ↗
• MalfunctionJul 12, 2017Material Rupture

  WHILE GAINING ACCESS TO THE LESION THROUGH COMMON FEMORAL ARTERY, THE BALLOON RUPTURED DURING INFLATION TO16 ATM. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6707954 ↗