Events

Recall of Device Recall Heartstring II Proximal Seal aortic cutter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Cardiac Surgery.

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
    32573
  • Event Risk Class
    Class 2
  • Event Number
    Z-1396-05
  • Event Initiated Date
    2005-07-05
  • Event Date Posted
    2005-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40373
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. use of the cutter on altered tissue has caused the aortic plug to not be captured by the device.
  • Action
    Notification to customers sent via FedEx on July 5, 2005, with product handling instruction sheet. Follow up communications to non-returning consignees will be recorded and documented.

Device

Device Recall Heartstring II Proximal Seal aortic cutter
  • Model / Serial
    HSK-2038, HSK-2043. All lots are affected by this recall.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 274 consignees. 15 are international distributors. 259 hospitals. The product is fully distributed to the following countries: USA, Belgium, CAnada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Israel, Italy, Lebanon, Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, and Swizerland. 3 VAs received product: 13000 Bruce B Downs Blvd, Tampla, FL, 800 Hospital Dr., columbia, MO, and 921 NE 13th st., Oklahoma City, OK.
  • Product Description
    Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
  • Manufacturer
    Guidant Cardiac Surgery

Manufacturer

Guidant Cardiac Surgery
  • Manufacturer Address
    Guidant Cardiac Surgery, 3200 Lakeside Dr, Santa Clara CA 95054-2807
  • Source
    USFDA