Defibrillator Recall

Cardiac defibrillators are small devices implanted into the body to regulate the heartbeat with people at-risk for heart problems. They work on small computers designed to detect an irregular heartbeat and then shock the heart into the proper rhythm. One of the leading retailers of cardiac defibrillators in the United States is recalling over 50,000 defibrillators due to possible defects. This defibrillator recall is based on the fact that it has been found that some of these devices are beginning to short circuit therefore causing problems in the wiring and as a result they are not working as they should.

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A safety warning was issued in recent months explaining to doctors and consumers what the problems were and what models were experiencing problems. It was also stressed that it was not all models, and that those people who had the original model implanted have nothing to fear as this model is working as it should. There are about seven models of defibrillators that are being recalled. The recalled models include the following:

The Guidant Corporation is advising all patients to have these devices replaced immediately to avoid any serious problems. Even though this company is recalling their products they are still under fire due to the fact that they apparently knew that there were problems with the Prizm 2 DR and continued to market it. Reports however, are failing to mention the fact that the company demanded a total redesign of the their product. This leads us to believe that they were aware of the problem and they had attempted to do something about it.

It was discovered by medical professionals that the Contak Renewal defibrillators built before August 26, 2004 were also experiencing problems. They were demonstrating a serious risk of short-circuiting and failing to function, as they should. It was with the discovery of this new issue that the Guidant Corporation finally decided to recall their products to check for problems. The executives of Guidant are advising all people who have either of the above mentioned models to have them checked by their doctor. There are some models such as the Prizm 2 DR that is experiencing memory problems that can be checked and fixed without removal. However not all models are the same and some may need to be removed and new ones implanted.

Each of the listed above are having their own distinct problems. The Prizm 2 DR is experiencing deterioration in a wire insulator within the lead connector block, in connection with other factors, results in a short to the backfill tube. This results in the inability of the device to perform properly. The problems have been found in any devices of this model that were made prior to an April 2002 change in the device. Problems with the Contak Renewal were found in the devices that were made on or before August 29, 2004. The problem with this model involves deterioration in a wire insulator that results in a short to the active titanium case and the product is therefore not able to deliver treatment to the patient.

To find what problems are present in other makes and models of defibrillators you can contact the Guidant website. The problems that have been found are also listed on the Health Canada website or you may wish to consult your physician. Doctors across the world have been supplied with a list of problems associated with each different model.

 

 

 

 

 

 

 

 


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