Events

Recall of Device Recall Distal Access Catheter (DAC)

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

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
    72247
  • Event Risk Class
    Class 2
  • Event Number
    Z-0116-2016
  • Event Initiated Date
    2015-08-19
  • Event Date Posted
    2015-10-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140343
  • 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, percutaneous - Product Code DQY
  • Reason
    One distal access catheter intended for distribution in korea, was found at a us location.
  • Action
    Issue was discovered by a sales representative during a visit for a case in Kentucky, where multiple Distal Access Catheters (DAC's) were being used. It was noticed that the reference number on one DAC carton did not match, even through the product labeling appeared to be the same. The mismatched unit was removed and returned to Concentric (Stryker). A formal recall letter was not issued as the product was returned after discovery. For further questions please call (510) 413-2263.

Device

Device Recall Distal Access Catheter (DAC)
  • Model / Serial
    Lot no. 37603 Expiration date: September 2016
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to one location in KY.
  • Product Description
    Distal Access Catheters - 044 - 115 cm: || Finished Good Number 90960-001 / REF 90960. || Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Manufacturer Address
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA