Recall Z-0003-2018 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
St Jude Medical Inc.
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura D
| Date | Oct 10, 2017 (initiated Aug 28, 2017) |
| Status | Terminated |
| Reason | The device may exhibit premature battery depletion. |
| Root cause | Device Design |
| Action | Abbott sent a Field notification letter dated August 28, 2017 to customers of the availability of the new Battery Performance Alert. The letter identified the affected product, problem and actions to be taken. The recalling firm posted a public statement on their website in the Abbott Media Room. The link to the statement is as follows: http://abbott.mediaroom.com/2017-08-29-Abbott-issues-new-updates-for-implanted-cardiac-devices. For questions contact your local Sales Representative or Abbott Technical Services at 1-800-722-3774. |
| Quantity | 90,563 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.