Advance G52280Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002522807), received between Apr 27, 2018 and Dec 19, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 18358171 ↗
• MalfunctionDec 1, 2020Material Puncture/Hole; Material Puncture/Hole

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10926832 ↗
• MalfunctionNov 14, 2018Material Rupture; Material Rupture

  IT WAS REPORTED, DURING A PERIPHERAL ANGIOPLASTY PROCEDURE TWO ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DEVICES RUPTURED. ACCORDING TO THE INITIAL REPORTER, THE RUPTURES OCCURRED ON THE BACK TABLE, DURING PREP, AND THE DEVICES NEVER MADE PATIENT CONTACT. IT WAS REPORTED THAT THE BALLOONS WERE INFLATED USING A MIX OF 2CC OF CONTRAST WITH 8 CC OF SALINE. IT WAS STATED THAT BOTH OF THE BALLOONS BURST AT 2-3 ATMS. IT IS UNKNOWN WHICH DIRECTION THE RUPTURES OCCURRED. ADDITIONALLY, A SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. SEE THE MANUFACTURER REPORT NUMBER 1820334-2018-03230 FOR THE SECOND BALLOON. THIS REPORT IS FOR THE FIRST BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 8072241 ↗
• MalfunctionApr 27, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, THE ADVANCE 35 LP LOW PROFILE BALLOON CATHETER WOULD ONLY INFLATE TO 2 ATMOSPHERES. THE PHYSICIAN WITHDREW THE COMPLAINT DEVICE AND EXCHANGED IT FOR A NEW ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE COMPLAINANT, A LEAK WAS FOUND NEAR THE VALVE OF THE DEVICE. ACCORDING TO THE INITIAL REPORTER, 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 7468625 ↗