Events

Recall of Device Recall VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Maquet Cardiovascular, LLC.

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
    59865
  • Event Risk Class
    Class 2
  • Event Number
    Z-3272-2011
  • Event Initiated Date
    2009-12-17
  • Event Date Posted
    2011-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103889
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    During routine production quality monitoring process, it was found that uv curing adhesive was not used in a limited number of devices.
  • Action
    MAQUET Cardiovascular, LLC, sent an "Urgent Device Removal/Immediate Action Required" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.

Device

Device Recall VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System
  • Model / Serial
    Part number: VH-3000; Lot # 9092471, Exp 8/31/2010
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: AL, AZ, CA, CT, FL, KS, KY, IL, IN, MI, MO, ND, NY, NV, OH, OK, OR, PA, SC, TN, TX, UT, WA, and WI.
  • Product Description
    VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System; || Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. || Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Manufacturer Address
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA