EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-5513...
FDA Device Recall #Z-2023-2012 — Class II — May 24, 2012
Recall Summary
| Recall Number | Z-2023-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 24, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | EKOS Corporation |
| Location | Bothell, WA |
| Product Type | Devices |
| Quantity | 21,892 units |
Product Description
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
Reason for Recall
EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation.
Distribution Pattern
Worldwide Distribution - USA including OH, KY, and TN and the countries of Switzerland, Germany, Austria, Czech Republic, Slovakia Republic, Poland, Netherlands, Belgium, Luxembourg, United Kingdom, Republic of Ireland, Slovenia, Costa Rica, Argentina, Brazil, Dominican Republic, Taiwan, Korea, Greece, Mexico, Italy, Uruguay, Paraquay, Yugoslavia, New Zealand, India, Venezuela, South America, Norway, Sweden, Denmark, Turkey, Great Britain, Israel, Spain, Portugal, Greece, Korea, China, and Japan.
Lot / Code Information
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Other Recalls from EKOS Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2890-2016 | Class II | The EKOS cart has the catalog number 700-60101.... | Aug 22, 2016 |
| Z-2854-2016 | Class II | EkoSonic Endovascular Devices EKOS Intellige... | Aug 9, 2016 |
| Z-0864-2016 | Class II | EkoSonic Endovascular System, Catalog Number 50... | Jan 21, 2016 |
| Z-2148-2015 | Class II | The EKOS EkoSonic Control Unit is intended excl... | Jun 24, 2015 |
| Z-0133-2014 | Class II | The EkoSonic Endovascular System employs high f... | Oct 2, 2013 |
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.