Events

Recall of Heartport

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, 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
    35335
  • Event Risk Class
    Class 2
  • Event Number
    Z-1101-06
  • Event Initiated Date
    2006-04-27
  • Event Date Posted
    2006-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45885
  • 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
    During cardiopulmonary bypass (cpb) the distal tip of the arterial cannula can become disconnected from the body of the cannula.
  • Action
    The recall was initiated on 4/27/2006. The hospitals were notified via letters to the Director of Material Management, Director of the OR as well as the Director of the Cardiovascular Suite in the US. The letters were sent via certified mail delivery. For international, notification was made to the J&J; affiliates (Gargrave and Italy) by the European Authorized Representative. Each country will follow local procedures for notitying customers.

Device

Heartport
  • Model / Serial
    Product Code DFK24 Lot Numbers: MS0206031; MS0206032; MS0505014; MS0505020; MS0605009; MS0605038; MS0605039; MS0705034; MS0705035; MS0705044; MS0905040; MS0905066; MS1105041; MS1105061; MS1205043.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    There are 25 direct customers. There are no distributors, wholesalers and retailers. The firm ships direct to the medical facility. There are 11 International customers located in United Kingdom and Italy.
  • Product Description
    Heartport Direct Flow Arterial Cannula, product code DFK24. The device is sold separately and also in the following Kit Model Numbers: EDNN241, EDnn242, EDNN243, and EDNN244.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Manufacturer Address
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA