Class 2 Device Recall Guidant Lead Tunneler Accessory Kit

• Date Initiated by Firm: June 13, 2005
• Date Posted: August 30, 2005
• Recall Status: Terminated 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
• FEI Number: 2124215
• Recalling Firm/ Manufacturer: Guidant Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: Guidant Technical Services; 800-227-3422
• 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: Other
• 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.