Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
FDA device recall Z-1449-2015 · posted 2015-04-15 · Terminated
Recall details
- Recalling firm
- Hansen Medical Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXX
- Quantity affected
- 19 total installed systems
- Distribution
- Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
- Date initiated
- 2015-03-18
- Date posted
- 2015-04-15
- Date terminated
- 2015-09-23
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAGELLAN ROBOTIC SYSTEM (K141614) | Hansen Medical | 2014-08-07 |
| MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR (K132369) | Hansen Medical, Inc. | 2013-09-27 |
| HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER (K111004) | Hansen Medical, Inc. | 2012-05-29 |