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Boston
Scientific Recalls Some Pacemakers and Defibrillators |
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| June 25, 2006 -- Boston Scientific announced that it is "retrieving" from hospital inventories and its sales force a specific subset of units that span various models of heart rhythm devices, including:
The company stated that the potential problem is not with all units of these models. Boston Scientific has identified a specific issue with certain lots of a small electrical component, a low-voltage capacitor, which is used to store an electrical charge. The capacitor, supplied by an outside manufacturer, is not performing to expectations and may lead to device malfunction, inability to deliver the required therapy or premature battery depletion. Chief Executive Officer Jim Tobin stated that the failure rate of the capacitor was very low and that, except for one batch, all the batches tested had none or only one failure. However, Tobin stated that the issue that upset him the most was that these capacitors were "clearly out of spec" and "how come that didn't get caught?" (Note: these devices were manufactured prior to Boston Scientific's involvement and purchase of Guidant -- Boston Scientific previously vowed when they purchased Guidant to put systemic manufacturing changes in place.) The company also issued letters to physicians and patients (links below) explaining the problem and alerting them how to take corrective action. The recommended action is to have the patient's device checked by the doctor for any of these identified defects. To date five cases have been identified out of over 27,000 implanted. This recall or "retrieval" is one of the first tests of Boston Scientific's ability to handle a device manufacturing problem with this class of products since it acquired Guidant two months ago. Guidant's heart rhythm unit has been the subject of much criticism and a number of pending lawsuits for witholding information about defects in its defibrillators and pacemakers. Boston Scientific recently pledged to be transparent in this regard and has wholly accepted the recent guidelines announced by the Heart Rhythm Society. The physician and patient letters were sent on Friday, and the press release issued on Sunday. The company stated in a conference call this morning that the reason it had decided to do all of this over a weekend was so company representatives had time to contact physicians directly and give them the complete information, and so the physicians did not first find out about this through the media (under Guidant, a year ago, many doctors found out about major device defect problems from an article in the New York Times). During the panel, Fred Colen, Boston Scientific's Chief Technology Officer, explained,
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