Advance Enforcer G35253Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002352534), received between Dec 19, 2017 and Jan 22, 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.

• MalfunctionJan 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A BALLOON ANGIOPLASTY PROCEDURE OF A DIALYSIS ACCESS CIRCUIT, AN ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED. THE PATIENT WAS REPORTED TO HAVE A HISTORY OF TYPE 1 DIABETES, DIABETIC NEUROPATHY, AND A HISTORY OF PREVIOUS INTERVENTIONS OF THE ACCESS CIRCUIT. THE PATIENT PRESENTED WITH A 70% RESTENOSIS OF A LEFT BRACHIOCEPHALIC FISTULA. THE TARGET VENOUS OUTFLOW LESION WAS LOCATED 1 CM DISTAL TO THE ARTERIO-VENOUS (AV) ANASTOMOSIS OR GRAFT-VEIN ANASTOMOSIS UP TO THE CONFLUENCE OF THE CEPHALIC AND AXILLARY VEINS. THE REFERENCE VESSEL DIAMETER (RVD) WAS 7MM AND THE LESION LENGTH WAS 2MM. THE COMPLAINT DEVICE WAS INFLATED TO 12 ATMOSPHERES WITH A 1:2 RATIO OF CONTRAST (OPTIRAY) TO HEPARINIZED SALINE WHEN THE BALLOON RUPTURED LONGITUDINALLY. ANOTHER MANUFACTURER'S BALLOON WAS THEN USED, WHICH ALSO RUPTURED. ANOTHER MANUFACTURER'S HIGH PRESSURE BALLOON WAS THEN USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266667 ↗
• MalfunctionDec 19, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING ILIAC OCCLUSION PREPARATION FOR A STENT, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER RUPTURED AFTER BEING SLOWLY INFLATED TO 10 ATMOSPHERE (ATM). THE ACCESS SITE USED WAS THE PATIENT'S FEMORAL ARTERY. A NEW BALLOON CATHETER WAS UTILIZED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7129599 ↗