Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in...
FDA Device Recall #Z-2598-2014 — Class II — June 25, 2014
Recall Summary
| Recall Number | Z-2598-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 25, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Concentric Medical Inc |
| Location | Mountain View, CA |
| Product Type | Devices |
| Quantity | 9 devices |
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.
Distribution Pattern
US Distribution including the states of PA, CA, TX, NM, and OH.
Lot / Code Information
Model Number 90109; Lot number 35695
Other Recalls from Concentric Medical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0116-2016 | Class II | Distal Access Catheters - 044 - 115 cm: Finish... | Aug 19, 2015 |
| Z-0528-2015 | Class II | Trevo Pro 4 Stent Retriever, Model number 8002... | Nov 13, 2013 |
| Z-0525-2015 | Class II | Distal Access Catheter: Model Numbers: 90121, ... | Sep 26, 2013 |
| Z-0655-2013 | Class II | FlowGate Balloon Guide Catheter; Manufactured ... | Dec 20, 2012 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.