Recall Z-0709-05 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
St Jude Medical
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
| Date | Apr 13, 2005 (initiated Mar 10, 2005) |
| Status | Terminated |
| 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. |
| 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 | 1488 |
| Distribution | Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.