WEB W5-6-4-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00842429110898), received between Apr 15, 2021 and Jan 23, 2026 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN ACOMM ANEURYSM RUPTURE, MULTIPLE IMAGES WERE OBTAINED TO DETERMINE THE PLACEMENT OF THE WEB AFTER IT HAD DETACHED. INITIALLY, THE IMAGES LOOKED FINE. A FINAL IMAGE WAS TAKEN ABOUT TWENTY MINUTES AFTER DETACHMENT, AND IT REVEALED A SLIGHT SLOWING OF CONTRAST AND BLOOD FLOW PAST THE DEVICE. AGGRASTAT WAS ADMINISTERED TO THE PATIENT, AND EVERYTHING CLEARED UP ABOUT TEN MINUTES AFTER ADMINISTRATION. FINAL IMAGES WERE TAKEN, CONFIRMING ALL VESSELS REMAINED OPEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER REPEATED VISUALIZATION AND ADMINISTRATION OF AGGRASTAT, THE BLOOD FLOW HAD RESUMED AS NORMAL. IT WAS DETERMINED THAT THERE WAS NO INCURSION OF THE WEB INTO THE PARENT VESSEL. NOTHING ADDITIONAL WAS PERFORMED AFTER RESUMPTION OF NORMAL BLOOD FLOW. THE PATIENT IS DOING WELL AND IS RECOVERING. IMAGES HAVE BEEN REQUESTED; HOWEVER, THEY ARE UNAVAILABLE.

  Patient problems: Reduced Blood Flow

  MAUDE report 24164931 ↗
• MalfunctionNov 30, 2022Device Dislodged or Dislocated; Premature Separation; Device Dislodged or Dislocated; Premature Separation

  IT WAS REPORTED THAT DURING TREATMENT OF AN ANEURYSM, THE WEB DID NOT DETACH FROM THE DELIVERY PUSHER. ADDITIONAL DETACHMENT CONTROLLERS WERE USED UNSUCCESSFULLY. THE DEVICES WERE REPORTED TO PASS THE PRIOR TO USE TESTING. THE WEB WAS MANIPULATED EXTENSIVELY AND WAS REPORTED TO MOVE, TILT WITHIN THE ANEURYSM. THE WEB DETACHED WITHIN THE ANEURYSM UNEXPECTEDLY HOWEVER, NOT IN ITS ORIGINAL POSITION. THE PATIENT WAS REPORTED TO BE RECOVERING WELL. NO SECONDARY INTERVENTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890462 ↗
• MalfunctionAug 30, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A WEB DEVICE WOULD NOT LOAD INTO THE MICROCATHETER. IT WAS DETERMINED THAT THE WEB'S SIZE WAS DIFFERENT FROM THE SIZE ON THE DEVICE'S LABEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324642 ↗
• DeathOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WEB DEVICE WAS USED FOR TREATING A RUPTURED MCA WIDE NECK ANEURYSM. THE CASE WENT VERY WELL AND PHYSICIAN WAS ABLE TO PLACE THE WEB SUCCESSFULLY ON THE FIRST ATTEMPT. DYNA CT SHOWED GOOD WALL APPOSITION AND ALL BRANCHES OPEN. FINAL ANGIOGRAPHY SHOWED SOME STAGNATION IN THE ANEURYSM, ALL VESSELS OPEN AND FILLING WELL. PATIENT WOKE UP OK AND WENT TO THE ICU TO RECOVER. REPORTEDLY, 45 MINUTES LATER THE PATIENT WAS SHOWING SIGNS OF A STROKE AND CT SHOWED A LARGE HEMORRHAGIC BLEED. AN OPEN CRANIOTOMY WAS PERFORMED TO EVACUATE THE BLOOD AND A VENTRICULOSTOMY PLACED. THE NEXT MORNING A REPEAT ANGIOGRAM SHOWED THE ANEURYSM WAS OCCLUDED AND THE PATIENT WENT BACK TO THE ICU. REPORTEDLY, THE PATIENT PASSED AWAY A DAY OR TWO LATER.

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke

  MAUDE report 12609584 ↗
• MalfunctionMay 6, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A WEB DEVICE WAS THE WRONG SHAPE AS COMPARED TO THE PACKAGING LABEL. THERE WAS NO PATIENT INJURY OR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11781827 ↗
• MalfunctionApr 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON REMOVAL FROM THE PACKAGING, A WEB DEVICE APPEARED TO BE LARGER THAN THE DEVICE SIZE SPECIFIED ON THE PRODUCT LABEL. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11668980 ↗

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.