|
GUIDANT PACEMAKERS RECALLED
In July 2005, Guidant Corp. issued a worldwide recall for their heart pacemakers, warning patients and doctors that their pacemakers may need to be replaced due to possible malfunction from a faulty sealing component. Nine models that were made between 1997 and 2000 have been recalled. The models concerned are:
PULSAR® MAX Models 1170, 1171, 1270
PULSAR Models 0470, 0870, 0970, 0972, 1172, 1272
DISCOVERY® Models 1174, 1175, 1273, 1274, 1275
MERIDIAN® Models 0476, 0976, 1176, 1276
PULSAR MAX II Models 1180, 1181, 1280
DISCOVERY II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
CONTAK TR® Model 1241
VIRTUS PLUS® II* Models 1380, 1480
INTELIS II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499
The recall was prompted after 69 recent reports of pacemaker failures involving consumers losing consciousness due to a halt in pacing or their pacemakers increasing to a rapid pace. This malfunction may cause moisture to leak into the device and affect the electronic controls. While the FDA was evaluating consumer reports, Guidant issued a voluntary Class I recall and offered to replace the pacemakers at no charge.
According to the American Heart Association, 197,000 pacemaker procedures are performed on U.S. patients each year. These pacemakers are designed to steady the heartbeat in case of failure. Between 1990 and 2002, 2.25 million pacemakers were implanted, 8,834 of which had to be removed when they malfunctioned.
Currently, Guidant faces approximately 100 lawsuits related to its defibrillator and pacemaker products. Guidant has also recalled thousands of defective implanted defibrillators.
Guidant is pending acquisition by Boston Scientific for $27 million.
|
 |
|
