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U.S. Department of Health and Human Services

Class 2 Device Recall VasoView

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 Class 2 Device Recall VasoViewsee related information
Date Initiated by FirmNovember 19, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on March 09, 2004
Recall NumberZ-0292-04
Recall Event ID 27884
510(K)NumberK020143 
Product Classification Laparoscope, Gynecologic (And Accessories) - Product Code HET
ProductGuidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
Code Information Lot-- Exp Date: 3081371-- 7/2004, 3081471-- 7/2004, 3081571-- 7/2004, 3081871-- 7/2004, 3081972-- 7/2004, 3082071-- 7/2004, 3082171-- 7/2004, 3082271-- 7/2004, 3082272-- 7/2004, 3082571-- 7/2004, 3082671-- 7/2004, 3082772-- 7/2004, 3082871-- 7/2004, 3082972-- 7/2004, 3090271-- 8/2004, 3090371-- 8/2004, 3090471-- 8/2004, 3090571-- 8/2004, 3090871-- 8/2004, 3090971-- 8/2004, 3091072-- 8/2004, 3091171-- 8/2004, 3091271-- 8/2004, 3091571-- 8/2004, 3091671-- 8/2004, 3091771-- 8/2004, 3091871-- 8/2004, 3091971-- 8/2004, 3092271-- 8/2004, 3092372-- 8/2004, 3092471-- 8/2004, 3092571-- 8/2004, 3092671-- 8/2004, 3100271-- 9/2004 
FEI Number 3000719698
Recalling Firm/
Manufacturer		 Guidant Cardiac Surgery
3200 Lakeside Dr
Santa Clara CA 95054-2807
For Additional Information ContactLaurie Wong
408-845-2014
Manufacturer Reason
for Recall		VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce2597 units
DistributionThere are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled product was distributed in the United States and internationally. Recalled product was distributed by the firm to one (1) government account: USAF Medical Center Keesler, 1301 I Street, Keesler Air Force Base, MS 39534, (228) 377-2778. International countries include: Puerto Rico, Belgium, Chile, France, Germany, Italy and Kuwait.
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.
510(K) Database510(K)s with Product Code = HET
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