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U.S. Department of Health and Human Services

Class 2 Device Recall Magellan Robotic Catheter System Accessory Kits

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  Class 2 Device Recall Magellan Robotic Catheter System Accessory Kits see related information
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  
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
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.
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
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.
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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