Medtronic withdraws defibrillator part

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

Related Articles:
FDA panel: Approve Medtronic stent. Report
Study questions Medtronic stent. Report
Medtronic's doc payments draw new fire. Report
Medtronic will settle accusations on kickbacks. Report

Read more on: Medtronic

Suggested Articles

Pfizer isn't giving up in biosims. This week, it unveiled launches to three Roche blockbusters, with two already on the market.

Novo Nordisk is betting big on GLP-1 Saxenda in its global obesity push, but England's cost watchdog is unimpressed with the drug's long-term outlook.

Tecentriq didn’t show benefit against simple observation at delaying cancer recurrence or death in patients with muscle-invasive urothelial cancer.