April 11, 2007 – Boston Scientific/Guidant has recalled approximately 73,000 Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). A faulty component in these devices can cause the batteries to use energy sooner than expected.
“No patients have been harmed, however some devices have required early replacement,” said William Young, Vice President, Reliability and Quality Assurance at Boston Scientific, Cardiac Rhythm Management, in an April 5th letter to patients.
According to the Food and Drug Administration in a report published April 11th, the chance that a given patient is affected by this problem is very small, but patients with one of the recalled devices should contact their physicians about what steps to take next. In most cases routine follow-up is all that will be required. In some cases more frequent device checks may be advised. Only in rare cases will a device need to be removed prematurely from a patient.
Patients who are unsure if they have a device affected by this recall should:
Contact their physicians
Contact Boston Scientific Technical Services at 1-800-CARDIAC
Go to Guidant’s Product Performance Resource Center web site at http://www.guidant.com/ppr/advis/2007_04_05.shtml.
For more information, see www.fda.gov.
Note: Guidant Corporation merged with Boston Scientific Corporation on April 24, 2006. Guidant Corporation became the Cardiac Rhythm Management division of Boston Scientific Corporation. The products being recalled are labeled with the Guidant name.