FDA accords Class I priority to Guidant’s recalled devices |
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Published
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Sun, 03 Jul 2005 21:05
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INDIANAPOLIS- The US Food and Drug Administration (FDA) has classified the recall of heart devices made by the Guidant Corporation, as a high priority. The agency has accorded a Class I priority to the recall of these devices. Class I happens to be the most serious of notations. This means that the device failure could lead to inevitable adverse health effects and could also prove to be fatal to the patient.
The products, which have been designated Class I include:
* 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 FDA says that its investigations found that there are electrical flaws within these devices and can potentially develop "an internal short circuit when attempting to deliver an electrical shock to the heart." In such a situation, the implanted device cannot avert abnormal heart rhythms. The main danger here is that there is no sign to judge if a device will fail.
A failure can be detected only after a device has malfunctioned. FDA estimates that such faulty devices number 42,000 worldwide. The agency has already received reports of two deaths caused as a result of the failure of these devices. Further, 20,600 such devices are still implanted.
However, the agency says that a Class I notation does not necessarily mean that a device must be removed. Patients are encouraged to consult with their physicians before arriving at any decision.
FDA has accorded a Class II priority to the recalls of Ventak Prizm AVT, Vitality AVT, and Renewal AVT devices, Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF devices. This means that the devices "may cause temporary or medically reversible adverse health consequences, but that the probability of serious adverse health consequences is remote."
Guidant has recommended that if the patients experience any of the following symptoms they must immediately contact their doctor:
* Patients are required to consult their doctors if they are not sure as to which model has been implanted.
* Patients should continue to keep normal doctor appointments.
* If the patient feels a shock, he/she should contact a doctor as soon as possible.
* If any ‘beeping’ sound is heard from the device, Guidant says that patients must get admitted to the emergency room.
This latest twist in the faulty devices saga throws another spanner in the proposed merger of Guidant with Johnson & Johnson, which has been valued at $25.4 billion.
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