Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy cardioverter/defibrillator with Biventricular Stimlation, Model V-355
FDA Recall Z-1333-2008 · Posted 2008-08-19
Recalling FirmSt Jude Medical CRMD
Recall StatusTerminated
Date Initiated2008-01-16
Date Terminated2012-04-03
Reason for 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 life saving therapy.
Firm Action
A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. 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.
Root Cause
Software design
Distribution Pattern
Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.