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U.S. Department of Health and Human Services

Class 2 Device Recall Identity

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  Class 2 Device Recall Identity see related information
Date Initiated by Firm October 06, 2006
Date Posted December 19, 2006
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-0298-2007
Recall Event ID 36619
PMA Number P880086 
Product Classification pacemaker - Product Code DXY
Product St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)
Code Information All Devices (all serial numbers for the devices referenced in the advisory.)
Recalling Firm/
Manufacturer		 St Jude Medical CRMD
15900 Valley View Ct
Sylmar CA 91342-3577
For Additional Information Contact Nestor Kusnierz
818-493-2587
Manufacturer 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.
FDA Determined
Cause 2		 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 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, 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DXY and Original Applicant = Abbott Medical
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