System, Catheter Control, Steerable

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

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.

Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table.

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.

Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufa

Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter.

Magellan Robotic Catheter Accessory Kits,

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.