Boston Sci Issues More Guidant Recalls
May 16, 2006Boston Scientific Corp. said it has warned physicians that another 996 defibrillators made by its Guidant unit may quit prematurely, leaving heart failure patients unprotected from sudden cardiac death.
No deaths or injuries have been linked to the battery failures, the Natick, Mass.-based company said Monday. The defect, a faulty low-voltage capacitor, was confirmed in 30 defibrillators removed from patients as of May 8, and is suspected in at least 46 devices still implanted, Boston Scientific said. The Guidant division that makes the defibrillators is based in Arden Hills.
The defibrillator models affected by the capacitor problem are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and the Contak Renewal 4 AVT. The products were manufactured in March 2005 and all used a capacitor from a single supplier, the company told patients. In a letter to patients, the Guidant unit advised doctors to schedule in-clinic appointments for patients as soon as possible to check the batteries of those devices.
Boston Scientific said it learned of the failures after purchasing Guidant Corp. on April 21. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the recall last year of 109,000 defibrillators linked to at least seven deaths. Many recalled devices were sold years after Guidant learned of the flaws and began making models free of the problem.