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Equalizer™ M001171060Recalls & reported problems

Boston Scientific Corporation · Occlusion Balloon Catheter · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729402367), received between Jan 11, 2021 and Jan 11, 2021 — classified as 1 malfunction.

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

Device problems

  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 11, 2021Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE BALLOON RUPTURED. A 7F 20MM X 100CM EQUALIZER BALLOON CATHETER WAS SELECTED FOR USE IN A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) OF AN 18MM SPLENORENAL SHUNT. DURING THE PROCEDURE, THE BALLOON RUPTURED WHILE INFLATING AT 4CC. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 11148224 ↗

Other Catheter, intravascular occluding, temporary devices

All Catheter, intravascular occluding, temporary devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.