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Heart Device Recipients Often Not Aware of Recalls
Date:5/15/2008

s at the University of Oklahoma, asked 165 patients with a variety of heart devices whether they'd want them removed if there was a recall or safety advisory.

Just 5 percent said they'd want the device removed immediately if there was a "recall," and 2.5 percent said they'd want it taken out if there was a "safety advisory."

The patients gave a variety of answers when asked what they thought the chances were that they'd experience a device recall, with 31 percent thinking it was one in 100,000.

Dr. Andrea Russo, an electrophysiologist at the University of Pennsylvania, said the results of the Maryland survey suggest that officials should stop using the word "recall" in favor of "safety device."

"The term 'recall' implies that the device will fail dramatically and the failure will be potentially 'life-threatening,' with the term implying that it should be 'taken out,'" she said. The reality, according to her, may be different.

"The types of failures may vary dramatically, and the outcome following 'failure' is also quite variable and not necessarily life-threatening," she said.

More information

Learn more about implanted defibrillators from the American Heart Association.



SOURCES: Bruce Wilkoff, M.D., director, cardiac and tachyarrhythmia devices, Cleveland Clinic; Timm-Michael Dickfeld, M.D., Ph.D., director, electrophysiology, Baltimore VA Medical Center, and assistant professor, University of Maryland; Andrea Russo, M.D., electrophysiologist, University of Pennsylvania, Philadelphia; May 15, 2008, presentation, Heart Rhythm Society's annual meeting, San Francisco


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