Advance G50237Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002502373), received between Jun 27, 2016 and Feb 22, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionFeb 22, 2017Sticking; Sticking

  IT WAS REPORTED, DURING A PERIPHERAL LOWER LEG CASE, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS BEING REMOVED OVER A V18 BOSTON SCIENTIFIC WIRE, AND THE BALLOON BECAME STUCK, AS IF THE WIRE WAS STICKY. THE WIRE AND BALLOON HAD TO BE REMOVED FROM THE PATIENT TOGETHER. ALSO DURING THE PROCEDURE, A RUBICON CROSSING CATHETER WAS USED WITH AN ABBOTT WIRE AND THE SAME DIFFICULTY OCCURRED. THE PROCEDURE WAS COMPLETED AND THE PATIENT REMAINED UNHARMED. THE USER FACILITY REPORTED THEY WERE UNSURE WHAT CAUSED THE DEVICES TO BECOME STUCK AND WHY THE WIRE BECAME STICKY. NO ADDITIONAL DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6349154 ↗
• InjuryJun 27, 2016Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  DURING A RIGHT FEMORAL ANGIOPLASTY PROCEDURE, FEMORAL PUNCTURE WAS CONDUCTED FROM THE IPSILATERAL APPROACH (RIGHT) . THE PHYSICIAN REPORTED DIFFICULT PUNCTURE DUE TO BODY HABITUS. A 4FR SHORT INTRODUCER WAS IN SITU. FOCAL CALCIFIED LESIONS NOTED ON INITIAL IMAGING THROUGH SFA. 0.014" WIRE (ANOTHER MANUFACTURER) WAS USED TO CROSS LESIONS. PRIMARY DILATION WITH 4MM BALLOON (COOK PTA4). SECONDARY DILATION WITH 5MM PTA4 BALLOON. BALLOON SEEN TO RUPTURE DURING PLASTY OF LESION IN MID SFA AREA. MAXIMUM PRESSURE USED OF 10ATM. A SMALL AMOUNT OF CONTRAST WAS SEEN TO REMAIN WITHIN THE RUPTURED BALLOON. NEGATIVE PRESSURE APPLIED WITH INFLATION DEVICE TO PROMOTE COMPLETE DEFLATION OF BALLOON. BALLOON WITHDRAWN OVER GUIDE WIRE UNTIL RESISTANCE FELT WHEN BALLOON REACHED PROXIMAL SFA. PHYSICIAN REPORTS APPLYING ADDITIONAL TENSION AT THIS POINT AS HE FELT THAT THE BALLOON WAS PARTIALLY WITHDRAWN INTO FEMORAL ACCESS SHEATH AND WAS PLANNING TO WITHDRAW BOTH THE RUPTURED BALLOON AND THE ACCESS SHEATH TOGETHER. THE PHYSICIAN REPORTS FEELING THE RESISTANCE ON THE BALLOON SUDDENLY GIVE. ON EXAMINATION OF WITHDRAWN SHEATH AND BALLOON, THE DISTAL TIP OF BALLOON CATHETER WAS MISSING. UNDER FLUOROSCOPY, DI

  Patient problems: No Code Available; Thrombus

  MAUDE report 5751490 ↗