WEB 17 SL 7x2 W5-7-2-MVI-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00842429118009), received between Oct 30, 2023 and Oct 18, 2025 — classified as 1 death, 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2025Separation Failure; Separation Failure

  AS REPORTED: PREPPED THE DEVICE ON THE BACK TABLE, DEPLOYED DEVICE IN SALINE AND GOT A GREEN LIGHT FROM THE DETACHER. DEPLOYED WEB IN ACOMM ANEURYSM AND CONTINUED TO GET A RED LIGHT WHEN WE WERE READY TO DETACH. TRIED A SECOND DETACHER AND CONTINUED TO BLINK RED. REMOVED THE WEB AND DEPLOYED A SECOND WEB AND DETACHED WITHOUT EVENT. THE DEVICE WAS DISCARDED BY THE USER FACILITY. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331504 ↗
• MalfunctionOct 17, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PHYSICIAN APPROACHED A RUPTURED PCOM ANEURYSM WITH AN ENVOY 6F 90CM CATHETER, A SOFIA 115CM, A STRAIGHT VIA17 AND A SYNCHRO14 GUIDEWIRE. THE PHYSICIAN THEN CHOSE A WEB 7X2MM DUE TO THE ANEURYSM SIZE (MEAN WIDTH 5MM, INFERIOR HEIGHT 5MM) AND PROPERLY PREPARED AND POSITIONED THE DEVICE INSIDE THE ANEURYSM. ONCE THE FIRST DETACHMENT ATTEMPT WAS MADE WITH A PROPER LOCK TENSION CONTROLLER MANEUVER AND WITH THE RIGHT SOUND AND LIGHT RESPONSES FROM THE WEB DETACHMENT CONTROLLER, THE DEVICE REMAINED CONNECTED TO ITS PUSHERWIRE. THE PHYSICIAN TRIED THEN TO DETACH THROUGH SOME PUSH AND PULL MANEUVERS WITH THE PUSHERWIRE OF THE WEB, THE MICROCATETHER AND EVENTUALLY THE SOFIA CATHETER, BUT THE WEB REMAINED CONNECTED TO THE PUSHERWIRE. DURING THE LAST ATTEMPT, THE PHYSICIAN PULLED THE WEB BACK INTO THE VESSEL AND DECIDED TO RESHEATH IT INTO THE SOFIA CATHETER AND NOT INTO THE VIA17 TO AVOID UNINTENTIONAL DETACHMENT DUE TO THE VIA17 INNER LUMEN SIZE. THEY SUCCESSFULLY PULLED SOFIA, VIA17 AND WEB OUT OF THE PATIENT, WITHOUT SEQUELAE AS CONFIRMED BY THE DIAGNOSTIC SERIES PERFORMED. THEN THE PHYSICIAN DECIDED TO USE A WEB SL 6X3MM WITH ANOTHER SOFIA 115CM AND A VIA17 MICROC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20477086 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Difficult or Delayed Separation; Detachment of Device or Device Component; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE EXPERIENCED A DELAYED DETACHMENT. WHEN RETRIEVING THE DEVICE, THE WEB DETACHED IN THE VIA. RETURNING VIA WITH WEB INSIDE. A 6X3 WAS USED IN IT¿S PLACE. PATIENT DOING WELL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454713 ↗
• DeathApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT ADDRESSES THE SECOND WEB DEVICE. THE FIRST WEB IS CAPTURED UNDER MFR REPORT#: 2032493-2024-00267. IT WAS REPORTED THAT A PATIENT ENROLLED IN THE WEB PAS STUDY HAD AN ACOM ANEURYSM TREATED WITH A WEB DEVICE ON (B)(6) 2024. THE DEVICE DID NOT DETACH WITH THE USE OF THREE DETACHMENT CONTROLLERS AND WAS REMOVED. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE, IT DETACHED WHEN IT WAS APPROXIMATELY 80-90% WITHIN THE CATHETER. THE DEVICE WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THE COMPANY WAS ADVISED THAT THE CASE WAS CONTINUED WITH A SECOND WEB DEVICE. WHEN THE WEB WAS BEING ADVANCED OUT OF THE TIP OF THE MICROCATHETER, THE OPERATIVE RECORDS REFLECTED THAT IT MIGRATED BEYOND THE ROADMAP, CAUSING CONCERN FOR RUPTURE. THE RECORDS FURTHER STATE THAT THE WEB WAS STUCK IN THE WALL OF THE ANEURYSM, AND, WHEN REMOVED, DID NOT FILL THE ANEURYSM PROPERLY DUE TO A SHARP TURN IN THE ANEURYSM. THE WEB WAS REMOVED. IT WAS REPORTED THAT EXTRAVASATION AND SUBARACHNOID HEMORRHAGE WERE OBSERVED AND THE ANEURYSM WAS TREATED WITH EMBOLIZATION COIL IMPLANTS. WHEN EXTRAVASATION WAS CONTROLLED, THE PATIENT WAS SENT FOR A VENTRICULOSTOMY TO CONTROL INTRACRANIAL PRESSURES ATTRIBUTABL

  Patient problems: Cerebral Edema; Extravasation; Intracranial Hemorrhage; Intracranial Pressure Increased; Ruptured Aneurysm

  MAUDE report 19037082 ↗
• MalfunctionApr 3, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  THIS REPORT ADDRESSES THE FIRST WEB DEVICE. THE SECOND WEB IS CAPTURED UNDER A SEPARATE REPORT. IT WAS REPORTED THAT A PATIENT ENROLLED IN THE WEB PAS STUDY HAD AN ACOM ANEURYSM TREATED WITH A WEB DEVICE ON (B)(6) 2024. THE DEVICE DID NOT DETACH WITH THE USE OF THREE DETACHMENT CONTROLLERS AND WAS REMOVED. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE, IT DETACHED WHEN IT WAS APPROXIMATELY 80-90% WITHIN THE CATHETER. THE DEVICE WAS REMOVED IN ITS ENTIRETY ALONG WITH THE CATHETER. THE COMPANY WAS ADVISED THAT THE CASE WAS CONTINUED WITH A SECOND WEB DEVICE. WHEN THE WEB WAS BEING ADVANCED OUT OF THE TIP OF THE MICROCATHETER, THE OPERATIVE RECORDS REFLECTED THAT IT MIGRATED BEYOND THE ROADMAP, CAUSING CONCERN FOR RUPTURE. THE RECORDS FURTHER STATE THAT THE WEB WAS STUCK IN THE WALL OF THE ANEURYSM, AND, WHEN REMOVED, DID NOT FILL THE ANEURYSM PROPERLY DUE TO A SHARP TURN IN THE ANEURYSM. THE WEB WAS REMOVED. IT WAS REPORTED THAT EXTRAVASATION AND SUBARACHNOID HEMORRHAGE WERE OBSERVED AND THE ANEURYSM WAS TREATED WITH EMBOLIZATION COIL IMPLANTS. WHEN EXTRAVASATION WAS CONTROLLED, THE PATIENT WAS SENT FOR A VENTRICULOSTOMY TO CONTROL INTRACRANIAL PRESSURES ATTRIBUTABLE TO SUBARACHN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036791 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ELECTIVE PROCEDURE, THE WEB WAS DEPLOYED IN THE ANEURYSM, AND POST-DEPLOYMENT, A DYNA CT ENCROACHMENT INTO THE PARENT VESSEL WAS OBSERVED. THE PHYSICIAN MADE THE DECISION TO RETRACT THE WEB DEVICE; HOWEVER, THROMBUS WAS OBSERVED IN THE WEB AND RETRACTION OF THE DEVICE WAS DIFFICULT. AFTER THE WEB WAS RETRACTED, THE DECIDED WAS MADE NOT TO CONTINUE TREATMENT AT THIS TIME. THE PATIENT WAS NOT IMPACTED AND REPORTED TO BE DOING WELL, AND THE TREATMENT OPTION FOR A LATER DATE WITH A WEB OR STENT COIL TREATMENT IS UNDER CONSIDERATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18156820 ↗
• MalfunctionOct 30, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE WEB DEVICE DID NOT DETACH. THE WEB WAS THEN ATTEMPTED TO BE REMOVED FROM THE PATIENT. DURING RETRACTION, THE CONFIGURATION WIRE DETACHED FROM THE PUSHER LEAVING HALF OF THE DEVICE STUCK INSIDE THE CATHETER, AND THE OTHER HALF OF THE DEVICE STUCK OUTSIDE THE CATHETER. THE ENTIRE SYSTEM WAS ABLE TO BE REMOVED FROM THE PATIENT SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR INTERVENTION. THE PATIENT IS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031149 ↗

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.