Advance G34372Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002343723), received between Jun 27, 2022 and Oct 14, 2022 — classified as 2 malfunctions.

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

• MalfunctionOct 14, 2022Break

  WE HAD A COOK BALLOON THAT WAS PLACED INTO THE PATIENT AND THE EXTERNAL PIECE NOT IN THE PATIENT BROKE AND WE WERE ABLE TO REMOVE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612124 ↗
• MalfunctionJun 27, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED, DURING TREATMENT OF THORACOABDOMINAL ANEURYSM, THE INFLATION PORT OF AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER CRACKED. THE DEVICE WAS INSERTED INTO THE LEFT FEMORAL ARTERY TO FLARE A COOK ZENITH FENESTRATED ENDOVASCULAR GRAFT. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED, AND NO RESISTANCE WAS FELT DURING INSERTION. AFTER THE BALLOON CATHETER WAS CONNECTED TO AN INFLATION DEVICE, THE INFLATION PORT FITTING CRACKED. A POWER INJECTOR WAS NOT USED. DURING ATTEMPTED INFLATION, SALINE WAS SPRAYED FROM THE CRACK IN THE FITTING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14827925 ↗