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
FDA Recall Z-0709-05 · Posted 2005-04-13
Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeNIK
Date Initiated2005-03-10
Date Terminated2005-07-11
Product Quantity1488
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.
Firm Action
Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
Root Cause
Other
Distribution Pattern
Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.