Z-0709-05

Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and...

Name: Z-0709-05 Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and...
Creator: St Jude Medical
Published: 2005-03-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-03-10 / Terminated

FDA source

St Jude Medical began a recall of Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic... on 2005-03-10. The reason FDA records is "Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0709-05
Status: Terminated
Initiated: 2005-03-10
Posted: 2005-04-13
Terminated: 2005-07-11
Recalling firm: Abbott Medical
Product: Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343
Product code: NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall: Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery.
FDA root cause: Other
Action: Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
Quantity in commerce: 1488
Distribution: Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
Product codes and lots: Too numerous to include here.

Product code NIK

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)