Recall Z-1015-03 ยท DXY Implantable Pacemaker Pulse-Generator
Guidant Corp-Cpi Division
Discovery II Multiprogrammable Pacemaker, Model 1284
| Date | Jul 15, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit. |
| Root cause | Other |
| Action | On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer. |
| Quantity | 50 pacemakers |
| Distribution | Nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.