Advance G30952Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002309521), received between Feb 28, 2020 and May 7, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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.

• InjuryMay 7, 2021Material Rupture; Material Separation; Material Rupture; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11789459 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  AS REPORTED, DURING ANGIOPLASTY OF OCCLUDED SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES VIA PEDAL ACCESS, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED. THE BALLOON WAS ADVANCED TO THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH ANOTHER MANUFACTURER'S 4 FRENCH SHEATH. THE ANATOMY WAS REPORTEDLY SEVERELY CALCIFIED; HOWEVER, TORTUOSITY WAS NOT REPORTED. ANGIOPLASTY WAS PERFORMED AND THE PHYSICIAN BEGAN TO WORK HIS WAY TO THE DISTAL SFA/POPLITEAL ARTERY. THE BALLOON RUPTURED AT EIGHT ATMOSPHERES UPON THE SECOND INFLATION, AFTER TEN SECONDS. A COOK HYDRO ST .014 WIRE, COOK INFLATION DEVICE, AND A 70/30 MIXTURE OF SALINE AND CONTRAST WERE USED DURING THE PROCEDURE. A "LITTLE BIT" OF BLOOD WAS REPORTED WITHIN THE INFLATION DEVICE AFTER THE BALLOON RUPTURED. THE BALLOON WAS REMOVED BY ITSELF. THE BALLOON WAS NOT INFLATED INSIDE OF A STENT. THE BALLOON WAS NOT REMOVED FROM THE BODY BETWEEN INFLATIONS. 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843620 ↗
• InjuryFeb 28, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  AS REPORTED, DURING AN ANGIOPLASTY AND ATHERECTOMY PROCEDURE OF A SEVERELY CALCIFIED SUPERFICIAL FEMORAL/POPLITEAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON WAS INFLATED WITHIN THE 85% OCCLUDED LESION ONE TIME TO FIVE ATMOSPHERES, USING AN UNKNOWN INFLATION DEVICE WITH ¿1.5¿ OMNIPAQUE CONTRAST AND ¿14¿ HEPARINIZED SALINE, AT THE TIME OF RUPTURE. THE BALLOON WAS UNABLE TO BE REMOVED OVER AN UNKNOWN WIRE GUIDE. AN UNKNOWN 6 FRENCH LONG SHEATH WAS INSERTED, AND THE COMPLAINT DEVICE, WIRE, AND SHEATH WERE REMOVED TOGETHER. A PORTION OF THE BALLOON REMAINED IN THE PATIENT, AS THE MARKER OF THE BALLOON COULD REPORTEDLY BE VISUALIZED INSIDE THE PATIENT. THE SIZE OF THE RETAINED SEGMENT IS UNKNOWN. THE BALLOON WAS NOT INFLATED INSIDE A STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9771084 ↗
• MalfunctionFeb 28, 2020Material Rupture; Material Separation; Material Rupture; Material Separation

  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 9769324 ↗