Events

Recall of Device Recall Sarns Soft Flow Aortic Cannulae

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

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
    63407
  • Event Risk Class
    Class 2
  • Event Number
    Z-0459-2013
  • Event Initiated Date
    2012-11-21
  • Event Date Posted
    2012-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113708
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    The presence of plastic flash was identified at the tip of certain lots of sarns soft-flow aortic cannula. the plastic flash has the potential to detach and contribute to an adverse patient effect. while this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl.
  • Action
    TERUMO sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2012, to all affected customers. The letter identified the product, the problem, and the aciton to be taken by the customer. Customers were instructed to remove this cannulae from circulation and return them for credit. Customers with questions should call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

Device Recall Sarns Soft Flow Aortic Cannulae
  • Model / Serial
    catalog number: 7071 and lot number: 0597322, 0602541, 0610241, 0615610, 0619197, 0620809, and 0620810.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL , CA , CO , DC , DE , FL , GA , IL , IN , KS , KY , LA , MA , MI , MO , MS , MT , NC , ND , NE , NH , NY , OH , PA , TN , TX , VA , and WI. Internationally to Australia, United Arab Emirates (UAE), Singapore, Malaysia, BELGIUM, Japan, and CANADA.
  • Product Description
    18 Fr 6mm Sft Flow Angled Wire || The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA