FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
- Recall number
- Z-1034-03
- Recalling firm
- Boston Scientific Corporation
- Product
- Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm Catalog no. 372906
- Status
- Terminated
- Initiated
- 2003-06-23
- Posted
- 2003-07-19
- Terminated
- 2018-10-03
- Reason
- Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa
- Root cause
- Other
- Action
- Boston Scientific notified sales representatives on 6/23/03 in foreign distribution area to remove product from inventory and contact hospital to retrieve and return.
- Quantity
- 30 units
- Distribution
- Japan, Italy, France, Turkey, Israel, Finland
- Lot, serial or model codes
- Lot Number: 5472234
- 510(k) numbers
- ["K955293"]
- PMA numbers
- not on file
- Product code
- not on file
- 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