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U.S. Department of Health and Human Services

Class 2 Device Recall VASOVIEW 4 Endoscopic Vessel Harvesting System

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  Class 2 Device Recall VASOVIEW 4 Endoscopic Vessel Harvesting System see related information
Date Initiated by Firm September 09, 2008
Date Posted December 23, 2008
Recall Status1 Terminated 3 on December 08, 2010
Recall Number Z-0476-2009
Recall Event ID 49550
510(K)Number K035012  
Product Classification Endoscope and accessories - Product Code GCJ
Product VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
Code Information model numbers VH-10242, lot numbers 7100172 to 8081371, and VH-10243, lot numbers 7100171 to 8081271.
Recalling Firm/
Manufacturer		 CTS, Inc. dba Guidant Cardiac Surgery
170 Baytech Dr
San Jose CA 95134-2302
For Additional Information Contact
408-635-6874
Manufacturer Reason
for Recall		 Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.
FDA Determined
Cause 2		 Packaging process control
Action The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness.
Quantity in Commerce 7,935 units
Distribution Worldwide Distribution --- including USA and country of Australia.
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.
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