FDA Medical Device Recalls (openFDA)
Stereotaxis Inc: Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
- Recall number
- Z-0590-04
- Recalling firm
- Stereotaxis Inc
- Product
- Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
- Status
- Terminated
- Initiated
- 2004-01-27
- Posted
- 2004-07-20
- Terminated
- 2005-10-31
- Reason
- The magnet at the end of the guidewire could break off.
- Root cause
- Other
- Action
- Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees.
- Quantity
- 76 guidewires
- Distribution
- The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands.
- Lot, serial or model codes
- Lots 0206-4004, 0207-4005, 0301-4015, 0301-4016, and 0304-4020
- 510(k) numbers
- ["K021363"]
- PMA numbers
- not on file
- Product code
- NFN
- Firm FEI
- 3003084417
- Firm city
- Saint Louis
- Firm state
- MO
- 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