WEB Aneurysm Embolization System W2-9-5-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00842429107201), received between May 16, 2023 and Sep 18, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED THROUGH A WEB PAS CLINICAL STUDY, AS REPORTED THAT AT 1 YEAR VISIT CEREBRAL ANGIOGRAM SHOWED COMPACTION AND RESIDUAL NECK REMNANT AT THE TREATED ANEURYSM. THE AE OUTCOME IS ONGOING. THE PATIENT IS ASYMPTOMATIC AND WILL REQUIRE RETREATMENT.

  Patient problems: Aneurysm

  MAUDE report 20252878 ↗
• InjuryMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE WEB CLINICAL TRIAL THAT A WEB DEVICE USED TO TREAT AN ANEURYSM MIGRATED CRANIALLY AND TO THE LEFT, WITH A RECURRENT ANEURYSM FORMATION AT THE NECK OF THE TREATED ANEURYSM. IT WAS REPORTED THAT RETREATMENT WAS DEEMED NECESSARY IN THE NEAR FUTURE. THE PATIENT WAS ALSO REPORTED TO HAVE EXPERIENCED SEVERE HEADACHES.

  Patient problems: Aneurysm

  MAUDE report 18926731 ↗
• MalfunctionJun 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED NOTES THE WDC-2 WAS NEVER USED ON THE WEB DEVICE ONCE IT ENTERED THE PATIENT. IT WAS ONLY USED DURING THE PREP TO CHECK THE WEB DEVICE. THE PHYSICIAN¿S TREATMENT PLAN WAS FOR THE FREDX 27 TO OPEN AND COVER THE ANEURYSM. BECAUSE THE FREDX 27 DID NOT OPEN HE DECIDED TO USE THE PIPELINE FLOW DIVERTER. THE HOSPITAL DOES NOT KEEP PIPELINE FLOW DIVERTERS IN THEIR INVENTORY, SO THE PATIENT NEEDED TO BE RESCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040605 ↗
• MalfunctionMay 16, 2023Material Invagination; Difficult or Delayed Separation; Material Invagination; Difficult or Delayed Separation

  SEE H10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943270 ↗

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.