Recall Z-1202-2017 ยท MGB Device, Hemostasis, Vascular
Abbott Vascular
StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
| Date | Feb 10, 2017 |
| Status | Terminated |
| Reason | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip. |
| Root cause | Other |
| Action | An urgent field safety notice will be sent to customers on 2/10/17 to inform them that Abbott Vascular has initiated a recall regarding specific lots of the StarClose SE Vascular Closure System. Customers are informed that product from the identified lots may exhibit difficulty or failure to deploy the StarClose SE Clip. Potential risks associated with this event include prolonged procedure times, use of another device or manual compression to achieve hemostasis. Customers are instructed of the actions to be taken and what Abbott Vascular is doing about the recall. Customers with any questi |
| Quantity | 170,008 units total (83,029 units in US) |
| Distribution | US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.