Reported Apr 22, 2015 · Terminated
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Hansen Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hansen Medical Inc · 800 E Middlefield Rd · Mountain View, CA · 94043-4030
Is this the product you have?
- Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 19 total installed systems
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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