Advance G50339Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002503394), received between Apr 17, 2018 and Oct 28, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Material Rupture; Material Rupture

  AS REPORTED, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED DURING AN UNKNOWN PROCEDURE. UPON RELEASE OF THE INFLATION DEVICE, THE USER NOTED THAT THE BALLOON HAD RUPTURED, AS BLOOD WAS COMING BACK THROUGH THE CATHETER. THE PHYSICIAN INITIALLY BELIEVED THAT THE BALLOON WAS FULLY REMOVED FROM THE PATIENT; HOWEVER, UPON CLOSER INSPECTION AND ADMINISTRATION OF CONTRAST UNDER FLUOROSCOPY, THE PHYSICIAN DISCOVERED THAT PART OF THE BALLOON AND RADIOPAQUE MARKER REMAINED IN THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE FRAGMENT FROM THE PATIENT; HOWEVER, THIS WAS UNSUCCESSFUL AND THEREFORE, THE RETAINED FRAGMENT WAS STENTED TO THE WALL OF THE SUPERFICIAL FEMORAL ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20544212 ↗
• MalfunctionJan 2, 2020Peeled/Delaminated; Peeled/Delaminated

  AS REPORTED, PRIOR TO PATIENT CONTACT DURING AN ANGIOGRAM OF THE LOWER LEG, "PLASTIC STRANDS" CAME OFF OF AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER BALLOON AS IT WAS WIPED DOWN. THE STRANDS WERE APPROXIMATELY ONE INCH IN LENGTH. THE DEVICE DID NOT MAKE PATIENT CONTACT. 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 Patient Involvement

  MAUDE report 9539150 ↗
• MalfunctionApr 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE PTAX4-14-170-4-16 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS REMOVED FROM IT'S PACKAGING, MATERIAL WHICH WAS DESCRIBED AS A FILM ON THE SURFACE OF THE BALLOON, APPEARED TO BE COMING OFF IT. THE BALLOON CATHETER WAS NOT USED FOR THE PROCEDURE. A SECOND PTAX4-14-170-4-16 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE NOR WERE ANY ADDITIONAL PROCEDURES REQUIRED.

  Patient problems: No Patient Involvement

  MAUDE report 7437540 ↗