Recent announcements in February and May 2005 by two of the World's leading heart-related medical device manufacturers, Medtronic and Guidant Corporation, Inc., that they manufactured and distributed defective ICD and CRT-Ds, have impacted thousands of implantees. In each instance, the devices have been implanted in patients for months, if not years, before the companies notified patients of the defects and, in the case of Guidant, the company has allegedly admitted that it knew about defects in some devices as early as 2002, yet failed to disclose those defects to consumers until May 2005. The Guidant defects came to light only after a 21 year old college student died when his Guidant device failed. Perhaps just as alarming, since the student's death, it has come to light that Guidant allegedly continued to distribute an allegedly defective ICD after Guidant knew of the defect and had repaired it in newer models.

Medtronic Devices Recalled

The problems in the industry began to unfold in February 2005 when Medtronic notified doctors for the first time of a defect in approximately 87,000 ICDs and CRT-Ds that were manufactured between April 2001 and December 2003 that may cause the defibrillators to short out, deplete the battery, and result in the defibrillators not working without any warning. If the devices fail when needed, the risk to the patient is potentially life threatening. The batteries that operate ICDs and CRT-Ds are contained in the implanted device and, therefore, to eliminate the potential defect, the device would have to be surgically removed from the patient and replaced. According to Medtronic, over 87,000 of the devices have been distributed worldwide and approximately 65,000 of the defibrillators were implanted in patients in the United States.

To date, Medtronic has not recalled the devices and has offered only limited and inadequate compensation to patients who have had the devices replaced. The Medtronic defibrillator models at issue in the February 2005 announcement included the following defibrillators manufactured between April 2001 and December 2003: Model 7230 Marquis VR; Model 7274 Marquis DR; Model 7232 Maximo VR; Model 7278 Maximo DR; Model 7277 InSync Marquis; Model 7289 InSync II Marquis; Model 7279 InSync III Marquis; and Model 7285 InSync III Protect.

On April 16, 2004, Medtronic announced that it was recalling two heart defibrillators, the Micro Jewell II Model 7223 Cx and the GEM DR Model 7271 ICDS, because they were linked to at least four deaths and one injury. Similar to the ICDs and CRT-Ds at issue in the February announcement, Medtronic said that some of these defibrillators have failed to charge properly, which can result in the late delivery or non-delivery of cardiac shock therapy. The FDA has classified this recall as a Class I recall, which means that the FDA believes there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are believed to still be in use.

Guidant Announces Recalls

Guidant notified doctors on May 24, 2005 about a design flaw in the Ventak Prizm 2 DR implantable defibrillators manufactured prior to November 2002 that has caused some units to malfunction and short circuit. According to the company, there have been 26 reports of failure including one death regarding these devices. The company estimates that there are some 24,000 people who currently have the defibrillators implanted in them.

On May 24, 2005, the New York Times reported that Guidant notified doctors only after learning that the New York Times was preparing an article about the devices. The New York Times further said that Guidant acknolwedged that it knew about the defective design and waited 3 years before telling pateients and their doctors about the problem.

On June 17, 2005, the FDA announced that Guidant was recalling the Ventak Prizm 2 DR Implantable Defibrillators manufactured before April 16, 2002 and further announced that Guidant would be recalling the following additional devices:

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. On June 17, Guidant further annunced that it had 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.

On June 24, Guidant advised physicians to halt use of five additional models of cardiac defibrillators. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs. The Renewal 3 and 4 AVT models were also included in Guidant's June 17, 2005 recall. Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion. The suspension affects 46,000 of these devices, Guidant said, without specifying how many have been surgically implanted in people's chests and how many may be on supply shelves. The Indianapolis-based company said it found four cases of an electrical failure that can prevent the devices from shocking an irregularly beating heart back into a normal rhythm, and a fifth is suspected. No injuries or deaths were reported.

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.

Additional Guidant Models Recalled

On June 26, 2006, Boston-Scientific, which aquired Guidant April 21, 2006 recalled several devices. The affected devices all were manufactured by Indianapolis-based Guidant. Devices affected include Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 cardioverter defibrillators.

Boston Scientific said it was asking its sales force and managers of hospital inventories to return some units of six models of defibrillators and pacemakers that have potentially faulty low-voltage capacitors, which are used to store electrical charges.

The Natick-based company did not specify how many units were being returned, saying the recall involved a "subset" of certain models of devices that are designed to maintain a steady heart rhythm. About 27,000 devices that could have the problem had already been surgically implanted in patients.

The company was advising doctors to check for signs of a malfunctioning capacitor, such as prematurely dead batteries or a device that stops working as intended to restore a normal heart rhythm.

Boston Scientific spokesman Paul Donovan said a letter the company sent to doctors did not recommend surgeries to remove potentially faulty devices. "Instead, we're recommending that people see their doctors at the earliest opportunity," Donovan said.

If you or a loved one has been implanted with one of the covered makes and model of cardiac defibrillators, you can make a claim on this site or call 1 (866) 467-1400 to speak to a lawyer now.