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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Lot Codes / Batch Numbers
Too numerous to include here.
Products Sold
Too numerous to include here.
A medical device manufacturer is recalling Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, due to Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electroca. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
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