Z-1564-2016Class II

Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical...

Name: Z-1564-2016 Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical...
Creator: Hansen Medical Inc
Published: 2016-03-25
License: https://open.fda.gov/license/

Hansen Medical, Inc. / initiated 2016-03-25 / Terminated

FDA source

Hansen Medical Inc began a recall of Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that... on 2016-03-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1564-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-25
Posted: 2016-04-25
Terminated: 2016-05-06
Recalling firm: Hansen Medical, Inc.
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.
Product code: DXX System, Catheter Control, Steerable
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 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 in commerce: 8 kits
Distribution: Nationwide Distribution to OH, TX. FL, CA and GA.
Product codes and lots: Lot number 20151117

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1564-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1564-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-25

Product code DXX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)