Boston Scientific to ship defibrillators
Written on April 16, 2010
Boston Scientific Corp. said Thursday it will begin shipping two types of implantable defibrillators, after shipments were halted in March when it was discovered that two manufacturing processes used in the production of the devices had not been cleared by the U.S. Food and Drug Administration.
The Natick, Mass., company is reporting that the FDA has cleared the manufacturing changes in question. The medical device maker said that it can meet customer demand for two of its product lines, Cognis and Teligen, within 24 hours.
However, the company reported that five other brands of defibrillators will continue to be recalled.
A company statement released Thursday read, in part, “Solely on its own initiative, the company has conducted an internal review of manufacturing and other changes for these products as well as the associated regulatory submissions. The review found a few additional instances where the company did not submit the appropriate documentation for validated manufacturing changes faxless pay day loans… The company has now submitted this documentation and is working closely with the FDA” to ship its entire line of defibrillators.
Early analyst predictions said the production freeze and recall could cost the company $470 million in sales.
Earlier this month, the Wall Street Journal said the company was being investigated by the Department of Justice and Securities and Exchange Commission, which raised questions over the recall.
Officials said they would update financial guidance with the impact of the ship hold and recall with their first quarter results, which are expected April 27.
Boston Scientific booked $8.2 billion in sales last year. The company’s CRM division, which manufactures the defibrillators affected in the recall, booked $1.7 billion in sales in 2009.
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