Recall Z-0528-2015 ยท NRY Catheter, Thrombus Retriever
Concentric Medical Inc
Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
| Date | Dec 8, 2014 (initiated Nov 13, 2013) |
| Status | Terminated |
| Reason | Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications. |
| Root cause | Process control |
| Action | The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 18, 2013 to all affected customers by traceable mail. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately locate the subject devices and quarantine them; distribute this notice to all affected departments in your facility; inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via fax to: 1-866-876-43 |
| Quantity | 10 units |
| Distribution | US Distribution to states of: CA, IN, PA, AL, and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120961 | TREVO RETRIEVER Concentric Medical, Inc., Aug 3, 2012 |