Advance G52299Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002522999), received between Mar 10, 2021 and Jun 2, 2022 — classified as 2 injuries.

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

• InjuryJun 2, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN INTERVENTIONAL PROCEDURE INVOLVING THE COMMON ILIAC VEIN, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. ANOTHER MANUFACTURER'S 8 FRENCH SHEATH AND 0.035-INCH J-WIRE WERE USED DURING THE PROCEDURE. THE BALLOON WAS INFLATED A TOTAL OF THREE TIMES, ONCE TO EIGHT ATMOSPHERES FOR TWENTY-FIVE SECONDS, ONCE TO TEN ATMOSPHERES FOR THIRTY SECONDS, AND ONCE TO FOURTEEN ATMOSPHERES, AT WHICH POINT THE BALLOON RUPTURED CIRCUMFERENTIALLY AND SUBSEQUENTLY SEPARATED INTO SEVERAL PIECES. MOST OF THE BALLOON WAS RETRIEVED WITH A SNARE; HOWEVER, A STENT WAS PLACED OVER A FRAGMENT THAT WAS UNABLE TO BE RETRIEVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14575655 ↗
• InjuryMar 10, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING DILATION OF A STENOSED STENT WITHIN A SHUNT USED FOR DIALYSIS, AN ADVANCE 35 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED WITHIN THE LEFT SUBCLAVIAN VEIN. THE DEVICE WAS INFLATED ONE TIME TO TWELVE BAR AT THE EDGE OF A PREVIOUSLY-PLACED, UNKNOWN STENT WHEN THE DEVICE RUPTURED CIRCUMFERENTIALLY AND SEPARATED "TRANSVERSELY". THE DISTAL TWO-THIRDS OF THE BALLOON EMBOLIZED TO THE LUNGS. THE REST OF THE BALLOON CATHETER WAS REMOVED WITH ANOTHER MANUFACTURER'S 7-FRENCH SHEATH. PER THE REPORTER, A CT SCAN FOUND A SMALL AMOUNT OF BALLOON MATERIAL IN THE LUNGS, WHICH REPORTEDLY POSES NO DANGER TO THE PATIENT. THERE ARE NO PLANS TO RETRIEVE THE SEPARATED BALLOON MATERIAL. BLOOD WAS NOT NOTED IN THE INFLATION DEVICE UPON RUPTURE. THE BALLOON WAS NOT INFLATED INSIDE THE STENT AND DID NOT GET CAUGHT ON THE STENT. 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: Foreign Body In Patient

  MAUDE report 11456296 ↗