Equalizer™ M001171070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729402374), received between Sep 11, 2018 and Sep 11, 2018 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2018Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS A STENT GRAFT LOCATED IN THE MODERATELY TORTUOUS VESSEL IN THE ABDOMINAL AORTA. A 27/7/2/65 EQUALIZER BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE THIRD INFLATION FOR 80 SECONDS, THE BALLOON RUPTURED. UPON DEVICE REMOVAL, IT WAS NOTED THAT A QUARTER OF THE BALLOON PART GOT SEPARATED. WHEN THE PHYSICIAN CHECKED INSIDE THE SHEATH, THE DETACHED BALLOON MATERIAL COULD NOT BE FOUND. ANGIOGRAPHY WAS PERFORMED ALL THE WAY TO THE PERIPHERAL AND IT WAS CONFIRMED THAT THERE WERE NO ISSUE WITH THE BLOOD FLOW. THE DETACHED FRAGMENTS OF THE BALLOON WERE NOT FOUND. THE PROCEDURE WAS COMPLETED WITH 17-107 EQUALIZER BALLOON CATHETER. NO FURTHER PATIENT COMPLCATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7866001 ↗