Recall Z-1564-2016 ยท DXX System, Catheter Control, Steerable
Hansen Medical Inc
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 Ma
| Date | Mar 25, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581. |
| Quantity | 8 kits |
| Distribution | Nationwide Distribution to OH, TX. FL, CA and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111004 | HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER Hansen Medical, Inc., May 29, 2012 |
| K132369 | MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR Hansen Medical, Inc., Sep 27, 2013 |
| K141614 | MAGELLAN ROBOTIC SYSTEM Hansen Medical, Aug 7, 2014 |
| K151730 | Magellan Robotic System Hansen Medical, Inc., Jul 23, 2015 |