Recall Z-0292-04 ยท HET Laparoscope, Gynecologic (And Accessories)
Guidant Cardiac Surgery
Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
| Date | Jul 20, 2004 (initiated Nov 19, 2003) |
| Status | Terminated |
| Reason | VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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) retailers and 123 hospitals that received the recalled product distributed by Guidant. The recalled pr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020143 | VASOVIEW 5 HARVESTING CANNULA Guidant Corporation, Cardiac Surgery, Feb 20, 2002 |