FDA Medical Device Recalls (openFDA)
Hansen Medical Inc: Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
- Recall number
- Z-1449-2015
- Recalling firm
- Hansen Medical Inc
- Product
- Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
- Status
- Terminated
- Initiated
- 2015-03-18
- Posted
- 2015-04-15
- Terminated
- 2015-09-23
- Reason
- 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
- 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
- 19 total installed systems
- Distribution
- Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K111004","K132369","K141614"]
- PMA numbers
- not on file
- Product code
- DXX
- Firm FEI
- 3006026430
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28