Z-0280-2009

7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard...

Name: Z-0280-2009 7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard...
Creator: C. R.Bard, Inc./BardElectrophysiology Division
Published: 2008-10-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-10-01 / Terminated / root cause: manufacturing process

FDA source

C. R.Bard, Inc./BardElectrophysiology Division began a recall of 7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard Electrophysiology. The product is Intended for introduction... on 2008-10-01. The reason FDA records is "Failure to insert the guidewire through the introducer needle". 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-0280-2009
Status: Terminated
Initiated: 2008-10-01
Posted: 2008-11-07
Terminated: 2010-03-09
Recalling firm: Boston Scientific Corporation
Product: 7F Bard SSV 13 cm Split Sheath with Valve and sideport Catalog Number: 808700 Distributed By: Bard Electrophysiology. The product is Intended for introduction of various type of pacing leads and catheters
Product code: DYB Introducer, Catheter
Reason for recall: Failure to insert the guidewire through the introducer needle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Bard issued a recall notice on 1 October 2008 [note that the letter is dated 29 September 2008] to all recipients of affected product via certified mail. Users are requested to discontinue use and return inventory. Contact Bard Customer Service at 1-800-824-8724 for assistance.
Quantity in commerce: 3,105 kits
Distribution: Nationwide
Product codes and lots: Lot Numbers: S25589 and S26178

Product code DYB

K934901Class IITear-Away Sheath Introducer Set with Integral Hemostasis ValveThomas Medical Products, Inc. / cleared 1994-01-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)