Home / Recalls / St. Jude Medical, Cardiac Rhythm Management Division / Z-1495-2022

Z-1495-2022 Class II Ongoing

Recalled by St. Jude Medical, Cardiac Rhythm Management Division — Sylmar, CA

Recall Details

Product Type
Devices
Report Date
August 10, 2022
Initiation Date
June 17, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
29,996 programs

Product Description

Merlin PCS 3650 programmer Model 3330 software

Reason for Recall

There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

Distribution Pattern

US: 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

Code Information

Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725

Other recalls by St. Jude Medical, Cardiac Rhythm Management Division

  • Z-1496-2022 Class II — Merlin 2 PCS MER37000 programmer Model MER3400 software (June 17, 2022)
  • Z-1497-2022 Class II — Merlin.net model MN5000 Software (June 17, 2022)
  • Z-0990-2022 Class II — Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q (March 10, 2022)
  • Z-0988-2022 Class II — Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q (March 10, 2022)
  • Z-0965-2022 Class II — Merlin 2 PCS MER3700 programmer Model MER3400 software (March 10, 2022)
  • Z-0964-2022 Class II — Merlin PCS 3650 programmer Model 3330 software (March 10, 2022)
  • Z-0989-2022 Class II — Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q (March 10, 2022)