FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
- Recall number
- Z-0328-2008
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific ACCUSTICK II Introducer System with .038 inch Stainless Steel J Tip and .018 inch Nitinol Guidewire, sterile, REF/Catalog No. 20-710; UPN/Material Number: M001207100, Boston Scientific Corporation, Natick, MA 01760
- Status
- Terminated
- Initiated
- 2007-07-19
- Posted
- 2007-12-07
- Terminated
- 2008-02-17
- Reason
- Marker Detachment: Out of specifications for pull strength, thus the marker may detach from the introducer during use.
- Root cause
- Process control
- Action
- Consignees were notified via an Urgent Medical Device Recall Letter sent federal express on 7/19/07, which requested them to check their stocks, remove product from inventory, and return the product.
- Quantity
- 249 (199 U.S.A. plus 50 international)
- Distribution
- Worldwide: USA and The Netherlands.
- Lot, serial or model codes
- Lot /Batch Number: 9498023.
- 510(k) numbers
- ["K952828"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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