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Drug & Device News
FDA Issues Nationwide Notification of Recall of Certain Guidant Products
The Food and Drug Administration (FDA) notified health care providers and patients on June 17 that the Guidant Corporation was recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators because the devices could develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.
The devices affected are the PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002; the CONTAK RENEWAL, manufactured on or before Aug. 26, 2004; and the CONTAK RENEWAL 2, Model H155, manufactured on or before Aug. 26, 2004. Problems were later disclosed concerning CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF. The FDA has declined to make a recommendation as to whether individual patients who have one of the Guidant devices should have it surgically removed and replaced because while the devices pose some risk to users, removal surgery also poses risks. The FDA has, however, warned patients that they should seek immediate medical assistance if they receive a shock from their devices or hear those devices beeping. Guidant has agreed to pay the cost of defibrillator replacement in certain cases.
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Major Differences In UK, U.S. Copyright Laws
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