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

FDA device recall Z-0896-2015 · posted 2014-12-30 · Terminated

Recall details

Recalling firm

Hansen Medical Inc

Reason for recall

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.

Action taken

Hansen Medical sent an Urgent Notice - Field Safety Notice letters to US customers on December 4, 2014 via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax back the attached form to Hansen medical at 650-404-2773. For further information call 650-404-5841.

Root cause

Device Design

Status

Terminated

Product code

DXX

Quantity affected

59 USA, 40 OUS

Distribution

Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.

Date initiated

2014-12-04

Date posted

2014-12-30

Date terminated

2015-09-03

Location

Mountain View, CA

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