Guidant recalled it’s implantable cardioverter defibrillators (ICD). These are the ones that require surgery and are placed inside the patient. Not the ones that are used externally to shock the heart back into rhythm during an emergency.

This is from the FDA website:

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.

“FDA’s first priority is patient safety,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health. “We want to ensure that all patients who may be affected by this problem are notified and seek appropriate medical advice from their physicians.”

FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

FDA advises patients to take the following steps:

If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
Continue to keep your regular doctor appointments.
If you feel an electrical shock from your device, immediately contact your doctor.
If there is an audible “beeping” from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.
Guidant also recently informed FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance. Currently, FDA is evaluating this information.

My grandmother had one of their pacemakers and it malfuction contributing to her death.

Denise- Oh no, I am so sorry about your Grandmother. But thank you for clarifying that information- it’s interesting this sponsor’s website doesn’t clarify what kind of defibrillator it is.

She beat me to it! I was going to post the same thing. I would ask the sponsor why this info was unclear.

When it comes to Guidant and Boston Scientific I probably know the ins and outs better then the company itself.

My grandma had her pacemaker put in August 2004. The first one failed in the recovery room and they wouldn’t tell us the make and model. They rushed her back to surgery to replace it. We have dealt with forged medical reports, ignorance from the company etc. In February 2005, my dad went to pick up grandma (his mother in law) to take her for her pacemaker check. She didn’t answer the door so he let himself in with our key and found her in full cardiac arrest in the middle of her dining room floor. She was pronounced dead 40 minutes later and the paramedics & ER doctor both said that the pacemaker was not working at the time. She was a very vibrant woman with so much love. It has been an agonizing 2 1/2 years trying to get this company to publish all it’s recalls and admit to the product liability.

The last words my grandma and I exchanged were I love you’s and for that I will always be grateful. I have google alerts set to pick up anything Guidant or Boston scientific which is how I happened on this post.

I have met several people that have lost a loved one due to this company including someone whose 1 year told granddaughter died in her arms and another whose 8 year old son was watching cartoons and died on the couch.

This company is a monster so please excuse me if my post came off a little sensitive or over the top.