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U.S. Department of Health and Human Services

Class 2 Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System

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  Class 2 Device Recall Heartstring II Proximal Seal/VASOVIEW 6 Endoscopic Vessel Harvesting System see related information
Date Initiated by Firm February 05, 2009
Date Posted December 13, 2010
Recall Status1 Terminated 3 on January 19, 2011
Recall Number Z-0614-2011
Recall Event ID 51242
510(K)Number K030512  
Product Classification Laparoscope, general; plastic surgery - Product Code GCJ
Product Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System,
Model Number: VH-2000,
Product is manufactured and distributed by Maquet Corporation
San Jose, CA
Code Information Affected Lot Number Range: 8030373 to 8112071
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		 Sterility may be compromised by a loss of package integrity.
FDA Determined
Cause 2		 Packaging
Action Maquet issued an Urgent Device Removal letter dated February 5, 2009 to customers, explaining the reason for the recall and requesting the product be returned for replacement. Customers were instructed to examine their inventory and discontinue distribution and use of the affected devices. Customers also were requested to complete and return a Field Action Response Form. Maquet can be contacted at 888-880-2874 concerning this recall.
Distribution Distribution: Nationwide and Internationally.
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 = GCJ and Original Applicant = GUIDANT CORP.
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