Medtronic Recalls Two Implantable Heart Devices Reuters - 04/16/04 - Medtronic Inc. on Friday said it was recalling two older models of certain heart devices after the company became aware of four deaths and one serious injury that could be related to the failure of a key part of one of them. Medtronic shares fell 6 percent in after-hours trading following the announcement of the Class 1 recall, which the U.S. Food and Drug Administration defines as a situation in which there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. The company said most of the recalled implantable cardioverter defibrillators (ICDs), which are used to shock the heart back into normal rhythm, were implanted in 1997 and 1998 and are close to the normal replacement time. The devices in question may take a longer than normal time to charge before delivering the life-saving jolt due to a possible problem with the capacitors, Medtronic said. The Minneapolis-based company no longer uses the capacitor technology in its newer ICDs. The recalled models are a subset of the Micro Jewel II Model 7223Cx, which had the capacitor problem, and GEM DR Model 7271, the company said. The Micro Jewel II is no longer sold. Medtronic said about 1,800 of the recalled ICDs are thought to be still implanted in patients worldwide. The company is working with the FDA to make sure physicians and their patients with the devices are notified of the recall. Doctors are being advised to check the charge time and battery voltage of each affected device. Medtronic said it was recommending replacement of any ICD that exhibits unsatisfactory charge times. A landmark long-term study last month showed that ICDs lowered the risk of sudden cardiac death by 23 percent in patients suffering from moderate heart failure.