FDA Recall
Terminated
Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
Recall: Z-0595-04
·
Initiated January 27, 2004
Recall
- Recall Number
- Z-0595-04
- Event Number
- 28254
- Firm
- Stereotaxis Inc
- FEI Number
- 3003084417
- Product Code
- NFN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 27, 2004
- Posted
- July 20, 2004
- Terminated
- October 31, 2005
- Address
- 4041 Forest Park Ave, Saint Louis, MO, 63108-3213
Description
Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1
Reason
The magnet at the end of the guidewire could break off.
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.
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.
Quantity
44 guidewires