Boston Scientific Suspending Sales of Implanted Heart Defibrillators – 2 Production Changes Not Cleared by the FDA
Posted Mar 15 2010 6:08pm
Here’s more bad news for the company with an expensive recall. In addition to “stent wars” the company also participates in this highly competitive area. Just last year the company received approval for a new stent, so I guess when they are not in court with J and J over “legally patented” stents, other items as such come to the surface and maybe the time in court is a bit distracting to taking care of business?
15 percent of the company revenue comes from the sale of defibrillators, so with the 1.7 billion to pay J and J, this may be a long haul. This not a recall so patients do not need to be concerned in that area, although over the last few years there have been a few of those too.
WASHINGTON — Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the best-selling devices.
The company said it uncovered two production changes that were not cleared with the Food and Drug Administration. Medical device makers are required to alert regulators to significant changes in life-sustaining devices like defibrillators, which help correct irregular heart beats.
The Natick, Mass.-based company said it will retrieve all the affected devices from suppliers and hospitals. It was unclear when the company would resume sales.
The company stressed there are no safety concerns with the devices and patients can continue using them as normal.
Sung estimated Boston Scientific will lose $5 million per day during the sales suspension.
The company said it is working with the FDA to resolve the situation as quickly as possible.