Recall Z-0052-04 ยท DXY Implantable Pacemaker Pulse-Generator
St Jude Medical
Pulse Generator
| Date | Oct 24, 2003 (initiated Jul 31, 2003) |
| Status | Terminated |
| Reason | Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals. |
| Root cause | Other |
| Action | Sales Representatives will personally contact the physicians, explain the situation, leave a technical memo and a list of implanted patients for the doctor to follow-up with. The ''Dear Doctor'' letter to accompany the representatives is dated 7/31/2003. Instruments not implanted will be returned for reprocessing. |
| Quantity | 775 |
| Distribution | Nationwide and to four VA Medical Centers in IA and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.