To Recall or Not Recall Guidant Medical Devices

The Food and Drug Administration is considering not using the word recall to warn patients and doctors about defective pacemakers and defibrillators at the request of the Heart Rhythm Society, a physicians' group struggling to deal with a loss of public confidence in the safety of implantable heart devices.

The word "recall" creates too much anxiety among patients and physicians. Patients who learn they have a faulty device often assume they need to have it removed immediately, even though the surgical procedure to replace the device typically involves more risk than leaving it in.

The Heart Rhythm Society released guidelines asking the FDA to use safety advisory or safety alert when referring to Guidant medical device problems.

The FDA has issued safety alerts and recalls affecting more than 337,000 defibrillators since 1990. On average, less than 5 in 1,000 pacemakers and 21 in 1,000 defibrillators have had malfunctions resulting in replacement. (PE.com)