Guidant Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Guidant Corporation
Lot Codes / Batch Numbers
lot number 104029 thru 105078
Products Sold
lot number 104029 thru 105078
Guidant Corporation is recalling Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contai due to A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath dur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026