Events

Recall of Device Recall Trevo XP ProVue System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Neurovascular.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78716
  • Event Risk Class
    Class 2
  • Event Number
    Z-0347-2018
  • Event Initiated Date
    2017-11-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160218
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter, thrombus retriever - Product Code NRY
  • Reason
    Stryker neurovascular has become aware that at least 1 (one) trevo xp provue system was manufactured where the carton sleeve did not match the physical contents of the pack.
  • Action
    The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.

Device

Device Recall Trevo XP ProVue System
  • Model / Serial
    UPN/Model No. 80052; Lot 63034
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OUS only - NL, FR, IT, DE, BE
  • Product Description
    Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Manufacturer Address
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA