Z-0595-04

Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1

Name: Z-0595-04 Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
Creator: Stereotaxis Inc
Published: 2004-01-27
License: https://open.fda.gov/license/

Stereotaxis Inc / initiated 2004-01-27 / Terminated

FDA source

Stereotaxis Inc began a recall of Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1 on 2004-01-27. The reason FDA records is "The magnet at the end of the guidewire could break off". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0595-04
Status: Terminated
Initiated: 2004-01-27
Posted: 2004-07-20
Terminated: 2005-10-31
Recalling firm: Stereotaxis Inc
Product: Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
Product code: NFN
Reason for recall: The magnet at the end of the guidewire could break off.
FDA 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 in commerce: 44 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.
Product codes and lots: Lot 0212-2027

Product code NFN

K021363Class IIEndovascular Guide WireStereotaxis, Inc. / cleared 2002-11-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)