Recall Z-1946-2016 ยท NIM Stent, Carotid
Cordis Corporation
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
| Date | May 4, 2016 |
| Status | Terminated |
| Reason | Inability to deploy the stent or partial stent deployment. |
| Root cause | Component design/selection |
| Action | Cordis sent an Urgent Medical Device Recall (Removal) letter dated May 4, 2016, to all affected customers. Action to be taken by the customer: 1) Immediately check your inventory to confirm whether you have any units from affected lots in your possession. Identify and set aside any units from the affected lot in a manner that ensures the affected product will not be used. Check all storage and usage locations. 2) Review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form. Note that you will receive multiple letters and Acknowle |
| Quantity | 4,400 units in US and 3,100 units in Foreign Countries |
| Distribution | NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.