FDAMarch 18, 2015device
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
hansen medicalhansen
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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