WEB Aneurysm Embolization System W4-6-3-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429107034), received between Jul 11, 2022 and Jul 11, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Separation Failure” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• DeathJul 11, 2022Separation Failure; Separation Failure

  AS REPORTED DURING A PROCEDURE TO TREAT A RUPTURED ANEURYSM WITH A WEB DEVICE, MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO DETACH THE WEB DEVICE FORM THE PUSHER WIRE. THE PHYSICIAN DECIDED NOT TO REMOVE THE WEB ONCE IT WAS DEPLOYED AS THE PHYSICIAN THOUGHT IT WOULD DO MORE HARM TO THE PATIENT TO REMOVE IT. THE PHYSICIAN ENDED UP LEAVING THE WEB IN PLACE AND CUTTING THE DELIVERY WIRE AT THE GROIN. THE WEB AND DELIVERY WIRE WERE LEFT IN THE PATIENT. THE PLACEMENT OF THE WEB WAS NOT IDEAL, AND A STENT WAS PLACED SO IT WOULD NOT MOVE. THERE ARE NO PLANS TO ADDRESS THE PUSHER, OTHER THAN LEAVING IT IN PATIENT. THE PATIENT WAS REPORTED TO BE DOING POORLY AND WAS SENT HOME ON HOSPICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Brain Injury

  MAUDE report 14983464 ↗

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.