More defibrillators, pacemakers recalled By MARK JEWELL, AP Business Writer

[Guest guest]

More defibrillators, pacemakers recalled By MARK JEWELL, AP Business

Writer

Mon Jun 26, 11:24 AM ET

 

 

 

BOSTON - Boston Scientific Corp. on Monday said it is recalling some

defibrillator and pacemaker models that could fail because of an

electrical flaw.

 

 

 

The recall is the latest in a string of product problems Boston

Scientific inherited when it bought Guidant Corp. in April for $27

billion.

 

Boston Scientific said it was asking its sales force and managers of

hospital inventories to return some units of six models of

defibrillators and pacemakers that have potentially faulty low-

voltage capacitors, which are used to store electrical charges.

 

The announcement sent shares of Boston Scientific down over 5

percent in morning trading to their lowest level in nearly four

years.

 

The Natick-based company did not specify how many units were being

returned, saying the recall involved a " subset " of certain models of

devices that are designed to maintain a steady heart rhythm. About

27,000 devices that could have the problem had already been

surgically implanted in patients.

 

Boston Scientific spokesman Paul Donovan said a letter the company

sent to doctors did not recommend surgeries to remove potentially

faulty devices.

 

" Instead, we're recommending that people see their doctors at the

earliest opportunity, " Donovan said.

 

The company was advising doctors to check for signs of a

malfunctioning capacitor, such as prematurely dead batteries or a

device that stops working as intended to restore a normal heart

rhythm.

 

The affected devices all were manufactured by Indianapolis-based

Guidant, which Boston Scientific acquired April 21. Devices affected

include Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2

cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality,

and Vitality 2 cardioverter defibrillators.

 

Boston Scientific said the capacitor that triggered the recall came

from an outside supplier.

 

Of the 27,000 implanted devices that may have the flaw, problems

have turned up in five patients, Boston Scientific said. None

involved deaths, but in two cases pacemaker patients temporarily

became unconscious.

 

In four cases, patients required surgery to replace devices. In

another, the malfunction was discovered when the device was being

implanted.

 

Shares of Boston Scientific fell 97 cents to $17.29 in midmorning

trading on the New York Stock Exchange. The company's shares

last traded in that range in the fall of 2002.

 

The company's stock has lost about a third of its value since

December, when Boston Scientific launched a bidding war against

Johnson & Johnson to purchase Guidant.

 

Since June 2005, Guidant has issued safety warnings or recalled more

than 88,000 defibrillators, and has recalled or issued warnings on

about 200,000 pacemakers. Boston Scientific also inherited liability

lawsuits connected with the products, which have been linked to at

least seven deaths.

 

Guidant had been criticized for failing to notify doctors, patients

and regulators of the extent of its product problems, and Boston

Scientific has vowed to do a better job.