Recall Z-2598-2014— Concentric Medical Inc

Name: FDA recall Z-2598-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-25

Class II · Terminated

Class II FDA medical device recall by Concentric Medical Inc, initiated 2014-06-25, terminated 2014-10-29. It names one FDA 510(k) clearance: K082034. Product: 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.. Reason: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date..

Recalling firm: Concentric Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Terminated: 2014-10-29
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082034 — MODIFICATION TO MERCI RETRIEVERConcentric Medical, Inc.·cleared 2008-08-15

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

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.

Reason for recall

Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.

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