Date Initiated by Firm |
March 25, 2016 |
Create Date |
April 25, 2016 |
Recall Status1 |
Terminated 3 on May 06, 2016 |
Recall Number |
Z-1564-2016 |
Recall Event ID |
73677 |
510(K)Number |
K111004 K132369 K141614 K151730
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Product Classification |
System, catheter control, steerable - Product Code DXX
|
Product |
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.
|
Code Information |
Lot number 20151117 |
Recalling Firm/ Manufacturer |
Hansen Medical Inc 800 E Middlefield Rd Mountain View CA 94043-4030
|
For Additional Information Contact |
Brian Sheehan 650-404-5581
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Manufacturer 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.
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FDA Determined Cause 2 |
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 in Commerce |
8 kits |
Distribution |
Nationwide Distribution to OH, TX. FL, CA and GA. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DXX and Original Applicant = Hansen Medical 510(K)s with Product Code = DXX and Original Applicant = HANSEN MEDICAL, INC.
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