Events

Recall of Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump

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
    76386
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2017
  • Event Initiated Date
    2015-05-27
  • Event Date Posted
    2017-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153034
  • 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
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Reason
    Terumo cardiovascular systems corporation has received complaints indicating that the sarns centrifugal pump (disposable pump heads) have exhibited leaks. the leaks were detected during priming of the bypass circuit and during cpb procedures. in each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. terumo cardiovascular system's investigation into the incident has identified the cause of the leaks to be cracks in both the top housing and magnet back housing of the pump. when the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
  • Action
    Customer Notification Letter/Response Form is being sent to all affected consignees.

Device

Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump
  • Model / Serial
    TAOS, TC03
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
  • Product Description
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA