Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
FDA device recall Z-0590-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Stereotaxis Inc
- Reason for recall
- The magnet at the end of the guidewire could break off.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NFN
- Quantity affected
- 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.
- Date initiated
- 2004-01-27
- Date posted
- 2004-07-20
- Date terminated
- 2005-10-31
- Location
- Saint Louis, MO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOVASCULAR GUIDE WIRE (K021363) | Stereotaxis, Inc. | 2002-11-27 |