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St. Jude Medical, Cardiac Rhythm Management Division Recall 90530

Description: Merlin PCS 3650 programmer Model 3330 software

St. Jude Medical, Cardiac Rhythm Management Division Recall 90530 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1495-2022
Event ID90530
Event DescriptionMerlin PCS 3650 programmer Model 3330 software
Product TypeDevices
DistributionUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VI VT WA WI WV WY , Guam OUS: ALBANIA ALGERIA ANGOLA Argentina ARMENIA Australia AUSTRIA AZERBAIJAN BAHRAIN Bangladesh BELGIUM BENIN BOLIVIA BOSNIA-HERZ. BRAZIL BULGARIA Burnei Cambodia CAMEROON Canada Chile China Colombia COTE D'IVOIRE CUBA CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REP. ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FAROE ISLANDS FINLAND FRANCE GEORGIA GERMANY GREECE GREENLAND GUATEMALA Hong Kong HUNGARY ICELAND India Indonesia IRELAND ISRAEL ITALY JORDAN KAZAKHSTAN KOSOVO KUWAIT KYRGYZSTAN LATVIA LEBANON LIBYA LIECHTENSTEIN LITHUANIA LUXEMBOURG MACEDONIA Malaysia MALTA MAURITIUS Mexico MONGOLIA MONTENEGRO MOROCCO Myanmar Nepal NETHERLANDS New Zealand NORWAY OMAN Pakistan PALESTINE PANAMA PARAGUAY PERU Philippines POLAND PORTUGAL QATAR ROMANIA RUSSIAN FED. SAUDI ARABIA SENEGAL Singapore SLOVAKIA SLOVENIA SOUTH AFRICA South Korea SPAIN Srilanka SUDAN SWEDEN SWITZERLAND Taiwan Thailand TRINIDAD TUNISIA TURKEY UKRAINE United Arab Emirates UNITED KINGDOM UZBEKISTAN VENEZUELA Vietnam VIRGIN ISLAND YEMEN ZAMBIA
Quantity29,996 programs
Recall ReasonThere is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
Device Classification20220810
Device Code InfoSoftware Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
Center Classification Date20220802
Recall Initiation Date20220617
Recalling FirmSt. Jude Medical, Cardiac Rhythm Management Division
Initial Notification Letter
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