Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236

FDA device recall Z-1327-2008 · posted 2008-08-19 · Terminated

Recall details

Recalling firm

St Jude Medical CRMD

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.

Action taken

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

Status

Terminated

Distribution

Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Ge

Date initiated

2008-01-16

Date posted

2008-08-19

Date terminated

2012-04-03

Location

Sylmar, CA