Merlin PCS 3650 programmer recall: Software Issue
Merlin PCS 3650 programmer Model 3330 software
Why was Merlin PCS 3650 programmer recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725
- Product
- Merlin PCS 3650 programmer Model 3330 software
- Recalling firm
- St. Jude Medical, Cardiac Rhythm Management Division
- Quantity
- 29,996 programs
- Distribution
- 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
- Recall date
- August 10, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)