Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Magellan Robotic System Recalled by Hansen Medical Inc Due to Based on investigation of two complaint incidents, all...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hansen Medical Inc directly.
Affected Products
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Quantity: 19 total installed systems
Why Was This Recalled?
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.
Where Was This Sold?
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
About Hansen Medical Inc
Hansen Medical Inc has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report