Z-1496-2022 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
622 programs

Product Description

Merlin 2 PCS MER37000 programmer Model MER3400 software

Reason for Recall

The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

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 MER3400 v1.1.2 rev 1 or earlier.; UDI/DI 05415067037121