Events

Recall of Device Recall Vado 8.8F Steerable Sheath

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

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
    78824
  • Event Risk Class
    Class 2
  • Event Number
    Z-0563-2018
  • Event Initiated Date
    2017-12-14
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160604
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.
  • Action
    The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.

Device

Device Recall Vado 8.8F Steerable Sheath
  • Model / Serial
    Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.
  • Product Description
    Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
  • Manufacturer
    Kalila Medical

Manufacturer

Kalila Medical
  • Manufacturer Address
    Kalila Medical, 745 Camden Ave Ste A, Campbell CA 95008-4146
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA