Events

Recall of Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CTS, Inc. dba 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
    51242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0614-2011
  • Event Initiated Date
    2009-02-05
  • Event Date Posted
    2010-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79407
  • 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
    Laparoscope, general; plastic surgery - Product Code GCJ
  • Reason
    Sterility may be compromised by a loss of package integrity.
  • Action
    Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.

Device

Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System
  • Model / Serial
    Affected Lot Number Range: 8030373 to 8112071
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution: Nationwide and Internationally.
  • Product Description
    Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, || Model Number: VH-2000, || Product is manufactured and distributed by Maquet Corporation || San Jose, CA
  • Manufacturer
    CTS, Inc. dba Guidant Cardiac Surgery

Manufacturer

CTS, Inc. dba Guidant Cardiac Surgery
  • Manufacturer Address
    CTS, Inc. dba Guidant Cardiac Surgery, 170 Baytech Dr, San Jose CA 95134-2302
  • Source
    USFDA