Boston Scientific Recalls Some Heart Devices

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Boston Scientific Corp. (NYSE:BSX) said on Monday it is recalling some heart devices from its sales force and hospital inventories because of defects that could to a malfunction.

The medical device maker said the items include some lots of the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers and Ventak Prizm 2, Vitality, and Vitality 2 implantable cardioverter defibrillators.

The company said it recently discovered that a faulty component may cause a malfunction in the device - including premature battery depletion.

The company said five confirmed malfunctions have been reported out of about 27,200 implanted devices from the group.

The company said no deaths have been reported.

"Clearly Boston Scientific shareholders are going to be tested once again," said Tao Levy, an analyst at Deutsche Bank Securities Inc. "On the outset, this problem could be very significant given the scope of the potential devices affected and leaves us wondering what type of mess Boston Scientific is left to fix."

Boston Scientific said it sent a letter to doctors alerting them to the issue. It said an engineering analysis was taking place and it will communicate further when it has additional information.

The company said doctors were being asked to schedule follow-up visits with patients who have been implanted with the devices as soon as possible to check that they are functioning properly.



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