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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 Recall
VASOVIEW 4 Endoscopic Vessel Harvesting System
see related information
Date Posted December 23, 2008
Recall Status1 Open
Recall Number Z-0476-2009
Recall Event ID 49550
Premarket Notification
510(K) Number
Product Classification Laparoscope, General & Plastic Surgery - 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, California 95134-2302
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
DESIGN: Packaging Design/Selection
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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