WEB W5-6-S-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842429110911), received between Jul 16, 2025 and Jul 16, 2025 — classified as 1 malfunction.

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 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.

• MalfunctionJul 16, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT VERY EXPERIENCED PRACTITIONER WHO IS FAMILIAR WITH THE WEB DEVICE WAS PLACING THIS DEVICE IN THE PATIENT'S ACOM VIA THE RIGHT SIDED, ARTERIAL APPROACH. DEVICE WAS SUCCESSFULLY DEPLOYED THROUGH A CATHETER AND LOOKED PERFECT. THE DEVICE WOULD NOT DETACH AND TRIED MULTIPLE DETACHMENT'S, TWO DETACHERS. AN ATTEMPT TO BRING THE CATHETER CLOSE TO THE DEVICE ONLY PROVED INEFFECTIVE AND RECAPTURED THE DEVICE. DEVICE WAS SUCCESSFULLY REMOVED, AND A DIFFERENT SIZE WEB WAS THEN USED TO SUCCESSFULLY TREAT THE PATIENT. NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22527697 ↗

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.