Recall Z-0004-2018 ยท NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
St Jude Medical Inc.
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibri
| 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 | 89,109 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.