St Jude Medical CRMD Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-197
Brand
St Jude Medical CRMD
Lot Codes / Batch Numbers
All serial numbers
Products Sold
All serial numbers
St Jude Medical CRMD is recalling Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-1 due to A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been ident. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026