FDA Recall
Terminated
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: Z-0709-05
·
Initiated March 10, 2005
Recall
- Recall Number
- Z-0709-05
- Event Number
- 31515
- FEI Number
- 2017865
- Product Code
- NIK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 10, 2005
- Posted
- April 13, 2005
- Terminated
- July 11, 2005
- Address
- St Jude Medical 15900 Valley View Ct, Sylmar, CA, 91342-3577
Description
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
Reason
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.
Action
Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.
Distribution
Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
Quantity
1488