Recall Z-0592-04 ยท NFN
Stereotaxis Inc
Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4
| Date | Jul 20, 2004 (initiated Jan 27, 2004) |
| Status | Terminated |
| 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 | 18 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021363 | ENDOVASCULAR GUIDE WIRE Stereotaxis, Inc., Nov 27, 2002 |