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WEB Aneurysm Embolization System W4-7-5Recalls & reported problems

Sequent Medical, Inc. · WEB 21 SL 7x5 · Class 3 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854111006150), received between Aug 9, 2019 and Aug 9, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

1 other recall cover devices cleared under the same FDA submission (P170032); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Difficult or Delayed Positioning1

Patient problems

  • Neurological Deficit/Dysfunction1
  • Thrombus1

Recent adverse event reports

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

  • InjuryAug 9, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

    IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN ANTERIOR COMMUNICATING (ACOMM) ARTERY ANEURYSM. AFTER PLACEMENT OF THE WEB IN THE ANEURYSM, IT WAS NOTED THAT THERE WAS A 30-40% PROTRUSION INTO THE A2 ARTERY, BUT THERE WAS NO FLOW RESTRICTION, SO THE WEB WAS DETACHED. WITHIN A COUPLE OF DAYS POST-PROCEDURE, THE PATIENT BEGAN HAVING SEIZURES. AN MRI WAS PERFORMED 3 DAYS AFTER THE PROCEDURE, WHICH DEMONSTRATED A CLOT AND STROKE IN THE LEFT A2 ARTERY. NO CLOT HAD BEEN VISUALIZED IN THE PROCEDURE ANGIOGRAMS. DUAL ANTIPLATELET THERAPY WAS ADMINISTERED, AS WELL AS A HEPARIN DRIP. CURRENTLY, THE PATIENT IS EXTUBATED BUT CANNOT MOVE HIS RIGHT ARM OR LEG.

    Patient problems: Neurological Deficit/Dysfunction; Thrombus

    MAUDE report 8881484 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P170032. One submission often covers many models, so check the product and lot details in each record.

  • Z-0170-2023 · Sep 21, 2022 · Open, Classified
    WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.

Other Intrasaccular Flow Disruption Device devices

All Intrasaccular Flow Disruption Device devices →

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