FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-215
- Recall number
- Z-1473-05
- Recalling firm
- Boston Scientific Corporation
- Product
- Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/8/1.6/2.6/63 Catalog Number : 45-215
- Status
- Terminated
- Initiated
- 2005-07-22
- Posted
- 2005-09-02
- Terminated
- 2007-06-20
- Reason
- The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- Root cause
- Other
- Action
- Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.
- Quantity
- not on file
- Distribution
- Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
- Lot, serial or model codes
- Lot Numbers: 904298 907475 916189 916193 916670 916671 917024 919478 919479 919973 920314 920761 922593 922982 924194 924849 926889 927902 927903 928721 931395 932992 933282 933688 937477 939043 939459 939785 940272 940576 943741 944476 944968 958507 968281 968733 969953 970275 973166 973517 974967 979015 979016 979610 985138 986235 986236 986237 1001730 1001731 1001732 1001733 1001734 1002346 1002347 1002348 1002349 1002766 1004052 958507D 968281D 968733D
- 510(k) numbers
- ["K030083"]
- PMA numbers
- not on file
- Product code
- KOB
- 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