Recall Z-0528-2015— Concentric Medical Inc

Name: FDA recall Z-0528-2015
Creator: U.S. Food and Drug Administration
Published: 2013-11-13

Class II · Terminated

Class II FDA medical device recall by Concentric Medical Inc, initiated 2013-11-13, terminated 2014-12-08. It names one FDA 510(k) clearance: K120961. Product: 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.. 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..

Recalling firm: Concentric Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2013-11-13
Terminated: 2014-12-08
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120961 — TREVO RETRIEVERConcentric Medical, Inc.·cleared 2012-08-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.