CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufact
FDA device recall Z-1493-06 · posted 2006-09-09 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
- Action taken
- A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXQ
- Quantity affected
- 480
- Distribution
- World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands
- Date initiated
- 2006-07-21
- Date posted
- 2006-09-09
- Date terminated
- 2008-11-19
- Location
- Miami Lakes, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORDIS REFLEX STEERABLE GUIDEWIRE (K930091) | Cordis Corp. | 1993-04-07 |