Escort II G21664Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002216648), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 other recall cover devices cleared under the same FDA submission (K953951); they may or may not involve this specific model.

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

• MalfunctionNov 17, 2017Burst Container or Vessel; Burst Container or Vessel

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED FOUR (4) ESCORT II EXTRACTION BALLOONS. THE BALLOONS BURST. ON (B)(6) 2017, TWO (2) OF THE DEVICES WERE RETURNED AND EVALUATED AND IT WAS DETERMINED THAT A SECTION OF ONE (1) OF THE BALLOONS WAS MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 7041833 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953951. One submission often covers many models, so check the product and lot details in each record.

• Z-0068-04 · Aug 28, 2002 · Terminated
  Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4