Advance Enforcer G35261Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002352619), received between Dec 17, 2018 and Mar 8, 2019 — classified as 2 malfunctions.

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 18, 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.

• MalfunctionMar 8, 2019Material Rupture; Material Rupture

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8404235 ↗
• MalfunctionDec 17, 2018Material Rupture

  THE COMPLAINANT REPORTED THAT THE DOCTOR HAD USED ANOTHER MANUFACTURER'S DEVICE AND PERFORMED THROMBOLYSIS. THERE WAS PERSISTENT INTRASTENT THROMBUS, SO THE DOCTOR NEEDED TO BALLOON THROUGH THAT. THE BALLOON ON THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED WHILE BALLOONING A SERIES OF STENTS. IT DID "WELL" AT BALLOONING THE TOP AND MIDDLE STENTS, BUT RUPTURED ON THE INFERIOR ASPECT OF THE WALL STENT. THE ENFORCER BURST LONGITUDINALLY AT A RATE OF APPROXIMATELY 6ATM (ATMOSPHERES). ANOTHER MANUFACTURER'S BALLOON WAS USED TO BALLOON THE DISTAL STENT, AND IT DID NOT RUPTURE. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169684 ↗