Guidant, Contak Renewal CRT: Class II Recall
MedSun: Newsletter #54, November 2010

FDA Recalls

Exposure to a magnet may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs. This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature.

MedSun has received reports with this device. To read the event, please see the link provided in Additional Information below.

Additional Information:

FDA Recalls. Guidant, Contak Renewal CRT: Class II Recall. October 7, 2010.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=94148

MedSun Report. April 2, 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=%25%22%2DK%3E%27%5FX%20%0A


MedSun Newsletters are available at www.fda.gov/cdrh/medsun