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U.S. Department of Health and Human Services

Class 2 Device Recall VASOVIEW 6 Endoscopic Vessel Harvesting System

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  Class 2 Device Recall VASOVIEW 6 Endoscopic Vessel Harvesting System see related information
Date Initiated by Firm December 17, 2009
Date Posted September 20, 2011
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-3270-2011
Recall Event ID 59865
510(K)Number K041981  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product VASOVIEW 6 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.
Code Information Part number: VH-2000; Lot # 9092171, Exp 8/31/2010
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Laurie Wong
408-635-0596
Manufacturer Reason
for Recall		 During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 141 units
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.
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
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