Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Ha...
FDA Device Recall #Z-1564-2016 — Class II — March 25, 2016
Recall Summary
| Recall Number | Z-1564-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 25, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Hansen Medical Inc |
| Location | Mountain View, CA |
| Product Type | Devices |
| Quantity | 8 kits |
Product Description
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.
Reason for Recall
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
Distribution Pattern
Nationwide Distribution to OH, TX. FL, CA and GA.
Lot / Code Information
Lot number 20151117
Other Recalls from Hansen Medical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1449-2015 | Class II | Magellan Robotic System; Model No(s). 11132 and... | Mar 18, 2015 |
| Z-0896-2015 | Class II | Sensei X Robotic Catheter System, model numbers... | Dec 4, 2014 |
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.