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U.S. Department of Health and Human Services

Class 2 Device Recall Vasoview Hemopro Endoscopic Vessel Harvesting System

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  Class 2 Device Recall Vasoview Hemopro Endoscopic Vessel Harvesting System see related information
Date Initiated by Firm October 30, 2013
Date Posted December 06, 2013
Recall Status1 Terminated 3 on April 24, 2015
Recall Number Z-0466-2014
Recall Event ID 66948
510(K)Number K052274  K101274  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information 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
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact
973-709-7498
Manufacturer Reason
for Recall		 Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
FDA Determined
Cause 2		 Component design/selection
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.
Quantity in Commerce 12,259 units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = GUIDANT CORPORATION
510(K)s with Product Code = GEI and Original Applicant = MAQUET CARDIOVASCULAR, LLC
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