FDA gives Boston Sci the go-ahead for recalled ICD, CRT-Ds

After more than one month of playing the waiting game, Boston Scientific has received the green light from the FDA to continue shipments of its Cognis cardiac resynchronization therapy defibrillators (CRT-D) and Teligen implantable cardioverter-defibrillators (ICDs) to the U.S. market.

On March 15, the company pulled all lots of the aforementioned products off the shelves after reportedly neglecting to inform the FDA of manufacturing changes.

Shortly after, the Wall Street Journal (WSJ) reported that the Department of Justice (DoJ) filed a subpoena about the issues, however, the company made no mention of the investigation.

According to the Natick, Mass.-based company, the FDA has approved the manufacturing changes and has allowed the company to begin shipment of its products.

Additionally, the company said that after conducting an internal review of its products, it has found that it has failed to submit proper documentation to the agency for manufacturer changes pertaining to its older versions of its ICD and CRT-D devices--Confient, Livian, Prizm, Renewal and Vitality.

Boston Scientific said that it has since submitted the appropriate documentation to the FDA and is waiting for approval that will allow the products to return to the U.S. device market. The issue does not affect countries outside the U.S.

Financial implications of the recall will be evaluated and appear in first quarter earnings. The company speculates that the actions may have had an impact on its revenue and profits for the full year of 2010.