Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236
Recall
- Recall Number
- Z-1327-2008
- Event Number
- 46870
- Firm
- St Jude Medical CRMD
- FEI Number
- 2017865
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- January 16, 2008
- Posted
- August 19, 2008
- Terminated
- April 3, 2012
- Address
- 15900 Valley View Ct, Sylmar, CA, 91342-3577
Description
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V-236
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.
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.
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.