Medtronic Recall given FDA’s most Serious Score

Jessica Smagacz

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This past Thursday, FDA said that thousands of Medtronic pacemakers may potentially cause serious injury or death, according to AP.

The pacemakers may have wiring defects that can cause them to malfunction. Medtronic is the world’s largest medical device company. There are 37,000 pacemakers that have this wiring defect.

FDA has classified this pacemaker as a Class I recall. This means that the device could “seriously or fatally injure patients.”

There are about 1.7 million of these pacemakers that have been implanted since 1997. “The defects affect a small subset of Kappa and Sigma pacemakers, causing them to not respond or run out of batter power.”

Over 95 percent of doctors were notified about this problem and have confirmed their receipt of the Medtronic’s letter.

“Patients should seek medical attention immediately if they experience fainting or lightheadedness, the company said in a statement.”