FDAnews Device Daily Bulletin

BOSTON SCIENTIFIC RECALLS CARDIAC DEVICES, VASCULAR GRAFTS

June 27, 2006
A A

Boston Scientific's Cardiac Rhythm Management (CRM) division and the FDA June 26 announced a recall of a specific subset of the firm's pacemakers, cardiac resynchronization pacemakers and implantable cardioverter-defibrillators (ICDs). The company discussed device-related safety issued in a letter to physicians dated June 23.

The recalled devices include Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators.

The recall notice can be viewed at http://www.fda.gov/oc/po/firmrecalls/bostonscientific06_06.html (http://www.fda.gov/oc/po/firmrecalls/bostonscientific06_06.html).

The letter to physicians can be viewed at http://www.guidant.com/physician_communications/060623.pdf (http://www.guidant.com/physician_communications/060623.pdf).

In related news, Boston Scientific and the FDA June 27 issued a worldwide recall of the firm's Hemashield Vantage vascular grafts manufactured in the past two years.

A vascular graft provides a tubular bypass for narrow or blocked arteries. The Hemashield Vantage recall was initiated because the device may fray or tear during suturing and lead to post-operative complications, the company said. Three device failures between three and seven days post-procedure were reported, and in each case the graft was resutured or replaced successfully, the company said.

To view the recall announcement, go to http://www.fda.gov/oc/po/firmrecalls/bostonsci06_05.html (http://www.fda.gov/oc/po/firmrecalls/bostonsci06_05.html).