Z-1442-05

Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one...

Name: Z-1442-05 Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array. Contains one...
Creator: Guidant Corporation
Published: 2005-06-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-06-13 / Terminated / root cause: manufacturing process

FDA source

Guidant Corporation began a recall of 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... on 2005-06-13. The reason FDA records is "A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1442-05
Status: Terminated
Initiated: 2005-06-13
Posted: 2005-08-30
Terminated: 2007-01-05
Recalling firm: Boston Scientific 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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 278
Distribution: nationwide and worldwide.
Product codes and lots: lot number 104029 thru 105078

Product code DYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)