Date: Thu, 12 Apr 2007 15:10:21 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA - MedWatch - Boston Scientific/Guidant Contak Renewal 3 & 4, Vitality, Vitality 2- Subset of Devices Recalled Because A Faulty Capacitor In The Devices Can Cause the Batteries to DepleteMedWatch - The FDA Safety Information and Adverse Event Reporting Program
Boston Scientific/Guidant and FDA informed healthcare professionals and patients that a subset of devices within the CONTAK RENEWAL 3 & 4, VITALITY and VITALITY 2 families were recalled. The recall included approximately 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of faulty capacitors.
The capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator and end of life to less than three months. Although the current recall is similar to the recall of May 2006, the failure modes and patient outcomes differ from those described in the May 2006 recall. Patients with one of the recalled devices should contact their healthcare provider regarding the next steps to take.
Read the complete 2007 MedWatch 2007 Safety summary, including a link to the manufacturer's Dear Doctor Letter and the FDA's Q&A document regarding this issue.
