Recall of Device Recall Stroke Fast Pack(TM)

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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 some 3-pack stroke fast packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.
  • Action
    Stryker notified their consignees by letter on 06/21/2017. The letter stated the following: This potentially impacts all 3-pack Stroke Fastpacks manufactured in the US. The product quality of the individual products in the Stroke Fastpack is not impacted. All units were manufactured to specification. We request that you read this notice carefully and complete the following actions: 1. Immediately check your internal inventory for impacted Catalog numbers. 2. Remove and discard the Stroke Fastpack carton sleeve. 3. Circulate this Field Safety Notice internally to all interested/affected parties. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. a) Please provide contact details so that Stryker can inform the recipients appropriately. 6. Please inform Stryker of any adverse events concerning the use of the subject devices. 7. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore please complete the form even if you no longer have any of the subject devices in your physical inventory. 8. Return the completed form to your nominated Stryker Representative or to


  • Model / Serial
    Lot Numbers: QPC30107530, QPC30107745, QPC30107814, QPC30110247
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
  • Product Description
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, || Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
  • Manufacturer


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