Z-0297-2007

St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia...

Name: Z-0297-2007 St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia...
Creator: St Jude Medical CRMD
Published: 2006-10-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-10-06 / Terminated / root cause: software

FDA source

St Jude Medical CRMD began a recall of St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650 on 2006-10-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0297-2007
Status: Terminated
Initiated: 2006-10-06
Posted: 2006-12-19
Terminated: 2012-03-26
Recalling firm: Abbott Medical
Product: St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650
Product code: KRG Programmer, Pacemaker
Reason for recall: 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 tag: software
FDA 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 St. Jude's website, www.sim.com Completion of this advisory is estimated to be three months after its initiation.
Quantity in commerce: 6,290
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, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA
Product codes and lots: All Devices (all serial numbers for the devices referenced in the advisory.)

Product code KRG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)