Recalling Firm / Manufacturer

St Jude Medical CRMD

Product

Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy cardioverter/defibrillator with biventricular stimulation, Model V-365

Code Information

All serial numbers

Reason of Recall

A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an arrhythmia. If an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially lifesaving therapy.

Date Recall Initiated

January 16, 2008

Action

A January 16, 2008, letter entitled, , sales representatives will follow-up with the physician and will upgrade all programmers.

In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.

Contact

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.