Class 1 Device Recall Penumbra 3D Revascularization Device

• Date Initiated by Firm: June 09, 2017
• Date Posted: June 22, 2017
• Recall Status: Terminated on May 09, 2019
• Recall Number: Z-2702-2017
• Recall Event ID: 77571
• 510(K)Number: K162901
• Product Classification: Catheter, thrombus retriever - Product Code NRY
• Product: 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 candidates for treatment.
• Code Information: Lots C00644, C00645, C00646, C00717
• Recalling Firm/ Manufacturer: Penumbra Inc.; 1 Penumbra; Alameda CA 94502-7610
• For Additional Information Contact: Michaela Mahl; 510-748-3288
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 no charge to them. Customers with question should call 1-510-748-3288.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NRY