DEVICE INFORMATION

NAME OF MANUFACTURER:
Thoratec Corporation

NAME OF DEVICE:

• Thoratec HeartMate II Left Ventricular Assist System (HM II LVAS)

NOTICE INFO:

The devices that are impacted by the notice:

• HeartMate II LVAS Catalogue No. 1355 or 102139 located on the package label
• HeartMate II LVAS distributed since November 2003
• HeartMate II LVAS distributed in the U.S., Canada, and elsewhere

DEVICE USE:
A ventricular assist device is a mechanical pump that helps the heart pump blood through the body.

FDA PRESS RELEASE:
Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II® Left Ventricular Assist System
FDA Web site — October 24, 2008

 

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Defective Thoratec® HeartMate II Ventricular Assist System Device May Cause Injury or Death

October 24, 2008
Thoratec issues worldwide “Urgent Medical Device Correction” Notice for HeartMate II Left Ventricular Assist System (LVAS) device.

• Worn and fatigued percutaneous leads could interrupt heart pump function, resulting in serious injury or death.
• Five patient deaths occurred when heart pump replacement was not feasible.
• Thoratec has confirmed 27 reports of wear and fatigue of the percutaneous lead requiring dangerous heart pump replacement surgery.

 

FDA Posts Press Release Listing the Affected Devices

The U.S. Food and Drug Administration has posted the Thoratec press release detailing the devices that are the subject of this medical device correction notice:

• HeartMate II Left Ventricular Assist System (HM II LVAS) Catalogue No. 1355 or 102139 located on the package label
• HM II LVAS distributed since November 2003
• HM II LVAS distributed in the U.S., Canada, and elsewhere

 

Worn Lead Can Cause Dangerous Malfunction
and Need for Surgery

A ventricular assist device (VAD) is a mechanical pump that helps a heart that is too weak to pump blood through the body. It is sometimes referred to as “a bridge to transplant” since it can help a patient survive until a heart transplant can be performed.     

According to the Thoratec notice, “Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death.”

Hospitals are being advised to replace a malfunctioning pump as soon as possible if damage to the percutaneous lead is confirmed.

If you or someone you know is being treated with a Thoratec HeartMate II Left Ventricular Assist System (HM II LVAS), a medical doctor should be consulted immediately to assess the wear and fatigue of the percutaneous lead and provide further treatment.

 

Contact a Personal Injury Attorney

The personal injury attorneys of Kershaw, Cutter and Ratinoff have handled hundreds of cases involving defective medical devices. Recently KCR has litigated and settled numerous cases involving the 2005 recall of defective Guidant® defibrillators and pacemakers.  We have assisted hundreds of individuals who were injured by defective Medtronic Sprint Fidelis defibrillator leads. Thus, we have the specific knowledge and experience needed to help our injured clients obtain fair compensation from companies such as Thoratec Corporation.

If you or a loved one is currently being supported by a HeartMate II Left Ventricular Assist System (HM II LVAS), you may be entitled to full payment by Thoratec Corporation for any additional surgery or medical treatment, as well as other damages including lost wages and pain and suffering.

Please fill out and submit the contact form on this page for a free case evaluation or call us toll-free at (888) 285-3333 to talk with a personal injury attorney.