Responding to the Recent Pacemaker Recalls

On July 22, the FDA issued a Class I recall for certain pacemakers manufactured by Guidant Corporation (see http://www.fda.gov/bbs/topics/NEWS/2005/NEW01210.html). A Class I recall means that if a particular device malfunctions, there is “a reasonable probability” of serious adverse health consequences or death.

Affected devices were manufactured between November 25, 1997, and October 26, 2000. They 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 …