Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VASOVIEW 4 Endoscopic Vessel Harvesting System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VASOVIEW 4 Endoscopic Vessel Harvesting Systemsee related information
Date Initiated by FirmSeptember 09, 2008
Date PostedDecember 23, 2008
Recall Status1 Terminated 3 on December 08, 2010
Recall NumberZ-0476-2009
Recall Event ID 49550
Product Classification Endoscope and accessories - Product Code GCJ
ProductVASOVIEW 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.
FEI Number 3000719698
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
ActionThe 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 Commerce7,935 units
DistributionWorldwide Distribution --- including USA and country of Australia.
Total Product Life CycleTPLC 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.
-
-