FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
- Recall number
- Z-1112-05
- Recalling firm
- Boston Scientific Corporation
- Product
- PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel, Sheath/Dilator, and caps. Firm on the label: Boston Scientific*** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
- Status
- Terminated
- Initiated
- 2004-05-25
- Posted
- 2005-08-10
- Terminated
- 2006-02-06
- Reason
- Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.
- Root cause
- Other
- Action
- Letters dated May 25, 2004 with instructions to return product to the Quincy, MA location.
- Quantity
- 290
- Distribution
- 278 units shipped to 31 consignees throughout the U.S. 12 units shipped to one foreign consignees located in the UK.
- Lot, serial or model codes
- 934445 exp. 2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007; 933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435 exp. 12/31/2006.
- 510(k) numbers
- ["K963806"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3001451463
- Firm city
- Natick
- 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