Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: Hansen Medical Inc
Category: Medical Device — Cardiac Catheter System
Hazard: crush-injury
cardiac-tamponade
uncontrolled-movement

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.

Same manufacturer · Hansen Medical Inc

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Moderate
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FDA (Devices) · 2016-05-04
High
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FDA (Devices) · 2015-04-22

Same hazard · crush injury