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Hansen Medical Recalls
3 recalls on record · January 7, 2015 to May 4, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 4, 2016Medical DevicesFDA
Hansen Medical Inc recalls Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan S
Hazard: Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
April 22, 2015Medical DevicesFDA
Hansen Medical Inc recalls Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
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.
January 7, 2015Medical DevicesFDA
Hansen Medical Inc recalls Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the S
Hazard: The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user.