Z-1344-2008

Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268

Name: Z-1344-2008 Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268
Creator: St Jude Medical CRMD
Published: 2008-01-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-01-16 / Terminated / root cause: software

FDA source

St Jude Medical CRMD began a recall of Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268 on 2008-01-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1344-2008
Status: Terminated
Initiated: 2008-01-16
Posted: 2008-08-19
Terminated: 2012-04-03
Recalling firm: Abbott Medical
Product: Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Model V-268
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.
Root cause tag: software
FDA root cause: Software design
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.
Distribution: 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.
Product codes and lots: serial numbers

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)