Guidant Recall

FDA Issues Nationwide Notification of Recall of Certain Guidant Implantable Defibrillators and Cardiac Resynchronization Therapy Defibrillators.

FDA is notifying health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification are:

   
* PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002   
* CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004   
* CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

The devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm.

The PRIZM 2 and RENEWAL devices are subject to different failures, resulting in the devices’ inability to deliver an electrical shock during episodes of arrhythmia — which could lead to a serious, life-threatening event for a patient. There have been two deaths reported to FDA suspected to be associated with this malfunction.

So, if you happen to have one of these, get out that wallet card and compare models and manufacturing dates.  Then, call your cardiologist!


Comments

  1. James B Willis, Jr says:

    I have a Model H179 implant; serial 501434.
    Is this affected by the recall ?

  2. Mr. Willis,
    SO far as this announcement goes, no, yours is not on the recall list. However, just to be sure please call your cardiologist to confirm your is not in the recall.

  3. Matthew Bressler says:

    My wife had a Guidant model 1861,
    implanted 2/2/02. Wife had one
    “jolt” from the device but a check
    on the device did not show a action
    by the device. Could this “false”
    or not recorded event, be an
    indication of possible failure?
    We have a meeting with the surgeon
    on 7/6/05. Any and all suggestions
    accepted.