Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
FDA device recall Z-0292-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Guidant Cardiac Surgery
- Reason for recall
- VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
- Action taken
- On 11/19/03, the firm issued letters via FedEx to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HET
- Quantity affected
- 2597 units
- Distribution
- There are a total of 130 consignees that received the recalled product distributed by Guidant. The firm has identified 0 (zero) wholesaler dealers, 7 distributors or affiliate companies, 0 (zero) reta
- Date initiated
- 2003-11-19
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-09
- Location
- Santa Clara, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VASOVIEW 5 HARVESTING CANNULA (K020143) | Guidant Corporation, Cardiac Surgery | 2002-02-20 |