Recall Z-2702-2017 ยท NRY Catheter, Thrombus Retriever
Penumbra Inc.
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) 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 ca
| Date | Jun 22, 2017 (initiated Jun 9, 2017) |
| Status | Terminated |
| Reason | Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. |
| Root cause | Component change control |
| Action | Penumbra sent an Urgent Voluntary Field Removal Notice dated June 9, 2017. Customers were instructed to inspect current inventory and remove any affected units for return. Customers were also instructed to return the response form. Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. Penumbra personnel will contact customers directly to arrange return of affected units and replacement of returned product at n |
| Quantity | 155 units |
| Distribution | Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162901 | Penumbra 3D Revascularization Device Penumbra, Inc., Apr 20, 2017 |