Recall Z-2598-2014 ยท NRY Catheter, Thrombus Retriever
Concentric Medical Inc
Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
| Date | Sep 8, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date. |
| Root cause | Process control |
| Action | Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of t |
| Quantity | 9 devices |
| Distribution | US Distribution including the states of PA, CA, TX, NM, and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082034 | MODIFICATION TO MERCI RETRIEVER Concentric Medical, Inc., Aug 15, 2008 |