Flawed Guidant Heart Devices
June 17, 2005: Guidant Corp. announced the recall of nearly 50,000 heart defibrillators that could short circuit without warning. As a result of the short circuit, the device can fail to deliver the necessary shock to the heart.
Less than a week later, Guidant issued a second safety advisory about its implantable defibrillators. The announcements continued on July 18, 2005, when Guidant Corp. revealed problems with an additional 28,000 implanted pacemakers and recommends that physicians consider replacing the devices.
What you should know:
Guidant is reported to have discovered design flaws in early 2002 after receiving two reports of failures. However, instead of immediately recalling the devices, Guidant chose not to notify patients with the original defective device -- or their doctors -- of the potential problem. Instead, they merely rectified the problem in new devices.
The matter recently came to light in March 2005 after the sudden death of a 21-year-old college student who had received the Guidant defibrillator due to a genetic heart disease. It was later determined that the student's defibrillator had short circuited. After investigation, Guidant informed the student's doctors that it was aware of 25 other cases in which the defibrillator had been affected by the same flaw.
Guidant has indicated that of the 78,000 suspect devices, up to 21,000 can be corrected by external reprogramming. The following models are included in the recall:
June 17, 2005 - Defibrillators Recalled:
- VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002
- CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004
- VENTAK PRIZM AVT; VITALITY AVT; RENEWAL 3 AVT; and RENEWAL 4 AVT ICDs (all series numbers)
June 24, 2005 - Defibrillator Advisory:
- CONTAK RENEWAL 3 and 4; RENEWAL 3 and 4 AVT; and RENEWAL RF
July 18, 2005 - manufactured between November 25, 1997 and October 26, 2000 - Pacemakers Recalled:
- PULSAR MAX; PULSAR; DISCOVERY; MERIDIAN; PULSAR MAX II; DISCOVERY II; VIRTUS PLUS II; INTELIS II and CONTAK TR
The FDA has classified some of the devices subject to recall under the 'highest priority' designation. Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said, "Malfunctions of these devices can lead to serious consequences and it's important for patients to call their doctor for additional information and personalized advice." What can I do?
If you have experienced any adverse effects from a Guidant heart defibrillator, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Ron Goldser directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.
Where can I find additional information?
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