FDA Medical Device Recalls (openFDA)
C. R.Bard, Inc./BardElectrophysiology Division: 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
- Recall number
- Z-0280-2009
- Recalling firm
- C. R.Bard, Inc./BardElectrophysiology Division
- 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
- Status
- Terminated
- Initiated
- 2008-10-01
- Posted
- 2008-11-07
- Terminated
- 2010-03-09
- Reason
- Failure to insert the guidewire through the introducer needle.
- 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
- 3,105 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: S25589 and S26178
- 510(k) numbers
- ["K934901"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1000120754
- Firm city
- Lowell
- Firm state
- MA
- 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