Events

Recall of 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
    66948
  • Event Risk Class
    Class 2
  • Event Number
    Z-0466-2014
  • Event Initiated Date
    2013-10-30
  • Event Date Posted
    2013-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124275
  • 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
    Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the hemopro vh-30000, "hemopro 1".
  • Action
    Maquet Inc. sent an Urgent - Medical Device Recall (Removal) Immediate Action Required Letter dated October 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please examine your inventory immediately to determine if you have any of the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (HEMOPRO 1) VH-3000 with the lot number(s), as specified above. The VH-3000 catalog number and lot number are located on the package label. Please remove the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and place in a secure location. NOTE: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 lot numbers not listed are not affected by this recall and should not be removed. HEMOPRO 2 is not affected by this recall. Your MAQUET Cardiovascular Sales Representative will contact you shortly to assist with the completion of the enclosed Acknowledgement Form (Fax Back Form), the return of any affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 product and arrange for necessary replacement. We apologize for any inconvenience this may cause. If you have any questions, please contact your local MAQUET Cardiovascular Sales Representative or MAQUET Customer Service at 1-888-880-2874, Monday through Friday, between the hours of 6:00 a.m. and 5:00 p.m. PST. Thank you for your cooperation and immediate assistance.

Device

Vasoview Hemopro Endoscopic Vessel Harvesting System
  • Model / Serial
    Catalog number VH-3000 (US) Lot numbers  25081686, 25081595, 25081460, 25081204, 25080939, 25080744, 25080418, 25080351, 25080264, 25079982, 25079913, 25073724, 25079449, 25079363, 25079086, 25078931, 25078713, 25078463, 25078291, 25078104, 25077927,25077643, 25077563, 25077123, 25076989, 25076372, 25076371, 25076133,   Catalog number  VH-3000W (Foreign) Lot numbers 25080938, 25080661, 25080311, 25078777, 25078289, 25078103 and 25077051
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.
  • Product Description
    Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 || Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
  • 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