FDA Medical Device Recalls (openFDA)
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 number
- Z-1442-05
- Recalling firm
- Guidant Corporation
- 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.
- Status
- Terminated
- Initiated
- 2005-06-13
- Posted
- 2005-08-30
- Terminated
- 2007-01-05
- Reason
- A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
- Root 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
- 278
- Distribution
- nationwide and worldwide.
- Lot, serial or model codes
- lot number 104029 thru 105078
- 510(k) numbers
- not on file
- PMA numbers
- ["P910073/S3"]
- Product code
- DYB
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28