Events

Recall of Device Recall Heartport

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heartport 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
    27410
  • Event Risk Class
    Class 3
  • Event Number
    Z-0311-04
  • Event Initiated Date
    2003-10-02
  • Event Date Posted
    2004-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30226
  • 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
    Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
  • Action
    Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.

Device

Device Recall Heartport
  • Model / Serial
    Lot number 020374
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Product Description
    Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
  • Manufacturer
    Heartport Inc

Manufacturer

Heartport Inc
  • Manufacturer Address
    Heartport Inc, Route 22 West, Somerville NJ 08876
  • Source
    USFDA