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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant Lead Tunneler Accessory Kit

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  Class 2 Device Recall Guidant Lead Tunneler Accessory Kit see related information
Date Initiated by Firm June 13, 2005
Date Posted August 30, 2005
Recall Status1 Terminated 3 on January 05, 2007
Recall Number Z-1442-05
Recall Event ID 32395
PMA Number P910073/S3 
Product Classification Introducer, Catheter - Product Code DYB
Product Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one tunneler and four sheaths. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue, St. Paul, MN 55112-5798.
Code Information lot number 104029 thru 105078
Recalling Firm/
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact Guidant Technical Services
Manufacturer Reason
for Recall
A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
FDA Determined
Cause 2
Action By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.
Quantity in Commerce 278
Distribution nationwide and worldwide.
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.