Events

Recall of CAPIOX FX Hollow Fiber Oxygenator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corp.

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
    61644
  • Event Risk Class
    Class 2
  • Event Number
    Z-1533-2012
  • Event Initiated Date
    2012-04-12
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108809
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Reason
    Loose connections (i.E., connections between pvc circuit tubing and oxygenator ports) may result in leaks and patient blood loss.
  • Action
    Terumo Cardiovascular Systems issued an Urgent Medical Device Recall notification on 4/12/12 to all user facilities/consignees who have received affected devices. The letter identified the affected product, stated the reason for the recall, the potential hazard involved, and the correction. Users are to review the letter, ensure that all users are made aware of the issue, discontinue use of the affected product, and return it to Terumo CVS. In addition, users are to return the response form to the manufacturer. Affected units will be replaced with new units. Contact Terumo CVS Customer Service @ 1-800-521-2818 or tcvs.recall@teruomedical.com

Device

CAPIOX FX Hollow Fiber Oxygenator
  • Model / Serial
    Lot No: NF09 ;  NG20 ;  NG20R ;  NH11 ;  NH11R
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including the states of AL, AZ, CA, MO, and NY and the country of Canada.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack || Product Code:72015-05 || Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
  • Manufacturer
    Terumo Cardiovascular Systems Corp

Manufacturer

Terumo Cardiovascular Systems Corp
  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA