FDA Medical Device Recalls (openFDA)
Boston Scientific Scimed: WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
- Recall number
- Z-1340-04
- Recalling firm
- Boston Scientific Scimed
- Product
- WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
- Status
- Terminated
- Initiated
- 2004-07-09
- Posted
- 2004-08-13
- Terminated
- 2007-01-05
- Reason
- Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
- Root cause
- Other
- Action
- Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
- Quantity
- 82 units (H965402100) aa7 units (H965402100)
- Distribution
- Inside the US only.
- Lot, serial or model codes
- 6541400, 6497027, 6256357, 6153225, 6091290, 6070085, 6013424, 5943551, 5903039, 5817491, 5796751, 5726023
- 510(k) numbers
- ["K992510"]
- PMA numbers
- not on file
- Product code
- JCT
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- 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