Z-2598-2014Class II

Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients...

Name: Z-2598-2014 Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients...
Creator: Concentric Medical Inc
Published: 2014-06-25
License: https://open.fda.gov/license/

Concentric Medical, Inc. / initiated 2014-06-25 / Terminated / root cause: manufacturing process

FDA source

Concentric Medical Inc began a recall of Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also... on 2014-06-25. FDA classified it as Class II and gives the reason as "Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2598-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-09-08
Terminated: 2014-10-29
Recalling firm: Concentric Medical, Inc.
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.
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.
Quantity in commerce: 9 devices
Distribution: US Distribution including the states of PA, CA, TX, NM, and OH.
Product codes and lots: Model Number 90109; Lot number 35695

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2598-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2598-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-08

Product code NRY

K082034Class IIModification to Merci RetrieverConcentric Medical, Inc. / cleared 2008-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)