FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310
- Recall number
- Z-1477-05
- Recalling firm
- Boston Scientific Corporation
- Product
- Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310
- 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: 897963 899779 905283 905540 905795 912253 912714 918871 919149 920316 926376 926666 934740 935754 937478 938097 938491 942049 942282 948073 953631 958509 958815 959675 968284 968734 969544 970794 972100 974707 975769 976229 978021 980595 981357 991171 991172 991173 991174 991438 992989 1000900 1000901 1000902 1001276 1002352
- 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