Z-1449-2015Class II

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical...

Name: Z-1449-2015 Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical...
Creator: Hansen Medical Inc
Published: 2015-03-18
License: https://open.fda.gov/license/

Hansen Medical, Inc. / initiated 2015-03-18 / Terminated / root cause: software

FDA source

Hansen Medical Inc began a recall of Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites on 2015-03-18. FDA classified it as Class II and gives the reason as "Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1449-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-18
Posted: 2015-04-15
Terminated: 2015-09-23
Recalling firm: Hansen Medical, Inc.
Product: Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Product code: DXX System, Catheter Control, Steerable
Reason for recall: Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. Retraction of catheter may not stop when equipment button is released.
Root cause tag: software
FDA root cause: Software design
Action: Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.
Quantity in commerce: 19 total installed systems
Distribution: Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1449-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1449-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-22	2015-04-15

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)