The Recall Desk
SevereFDA (Devices)·Z-0896-2015·Announced 2015-01-07

Hansen Medical Recalls Sensei X Robotic Catheter Systems Due to Loose Clamp

Hansen Medical is recalling Sensei X Robotic Catheter Systems because a mechanical clamp may become loose, causing the device to fall and potentially injure patients or users.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that poses a risk of significant injury, including cardiac tamponade and crush injury, which aligns with the 'Severe' criteria for significant injury reports or structural defects.

Plain-English summary

Hansen Medical Inc is recalling the Sensei X Robotic Catheter System, model numbers 02057 and 08257. The recall involves the Set Up Joint (SUJ) mechanical clamp that secures the system to the catheter laboratory table. The product is an electromechanical software-controlled system designed to facilitate navigation and control of robotically steerable catheters for collecting electrophysiological data within the heart atria.

The recall is being issued because the Set Up Joint subassembly may become loose relative to the operating table. This defect creates a potential for the device to fall, which could result in uncontrolled catheter movement, cardiac tamponade, delayed procedure, or crush injury to the patient and/or user.

A total of 99 units are affected, with 59 units distributed in the USA and 40 units distributed outside the US. The products were distributed worldwide, including in Italy, the Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, the Netherlands, and Australia. All installed Sensei X Robotic systems with these model numbers are subject to this action.

The recalled product

Product
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. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to f
Manufacturer
Hansen Medical Inc
Category
Medical Device — Cardiac Catheter System
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model numbers 02057 and 08257
  • all installed Sensei X Robotic systems are subject to this action.

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Hansen Medical Inc

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Same hazard · crush injury

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