Food, drugs, devices › Concentric Medical Inc
Device recall: Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing isc
FDA enforcement event 69119 is a device recall by Concentric Medical Inc of Mountain View, CA, initiated 25 Jun 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 29 Oct 2014. Initiation: voluntary: firm initiated. Concentric Medical Inc has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Concentric Medical Inc, Mountain View, CA.
Reason for recall
"Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date."
Distribution
"US Distribution including the states of PA, CA, TX, NM, and OH."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2598-2014 | 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. | 9 devices | Class II | Terminated | 17 Sep 2014 |
Context
Other enforcement events for Concentric Medical Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Aug 2015 | Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Cathet | Device | Class II | 1 |
| 13 Nov 2013 | Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore bl | Device | Class II | 1 |
| 26 Sep 2013 | Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in fac | Device | Class II | 1 |
| 20 Dec 2012 | FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate&amp | Device | Class II | 1 |
All 5 events for Concentric Medical Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution including the states of PA, CA, TX, NM, and OH."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Oct 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.