Medtronic is pulling a defibrillator component from the market in a move that affects some 235,000 patients. The company's Fidelis electrical lead, the connection between a heart and an implanted defibrillator, has malfunctioned in some patients and may have caused five deaths. The lead has been used with Medtronic defibrillators since 2004. Data about possible malfunctions began to emerge in March, when the company sent a letter to doctors warning of potential problems.
The company will stop selling the lead and recall all those that haven't yet been implanted. In most cases, doctors can reprogram the implanted defibrillators to minimize the problem without surgery. Defibrillators are Medtronic's biggest product segment, accounting for 55 percent of its sales. Now, the company is pledging to go back to the drawing board to develop a new electrical lead to replace the faulty Fidelis.
- see this release from Medtronic
- read the article from the New York Times
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