Recall Z-0298-2007 ยท DXY Implantable Pacemaker Pulse-Generator
St Jude Medical CRMD
St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
| Date | Dec 19, 2006 (initiated Oct 6, 2006) |
| Status | Terminated |
| Reason | St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status. |
| Root cause | Other |
| Action | The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th. In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on |
| Quantity | 199,065 |
| Distribution | Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.