Z-1495-2022Class II

Merlin PCS 3650 programmer Model 3330 software

Name: Z-1495-2022 Merlin PCS 3650 programmer Model 3330 software
Creator: St. Jude Medical, Cardiac Rhythm Management Division
Published: 2022-06-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-06-17 / Open, Classified / root cause: software

FDA source

St. Jude Medical, Cardiac Rhythm Management Division began a recall of Merlin PCS 3650 programmer Model 3330 software on 2022-06-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1495-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-17
Posted: 2022-08-02
Recalling firm: Abbott Medical
Product: Merlin PCS 3650 programmer Model 3330 software
Product code: DXY Implantable Pacemaker Pulse-Generator
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.
Root cause tag: software
FDA root cause: Software design
Action: On June 16, 2022 Abbott issued a "Medical Device Correction" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: 1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications). 2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling. 3. Please direct any questions about device longevity to Abbott Technical Support at 1-800-722-3774 (U.S.). 4.Upon programmer software / remote monitoring software update, the improved longevity estimate will be displayed at the patient s next interrogation. Please note that until programmers are updated, a difference in longevity estimates between programmers and remote monitoring (Merlin.net) may be observed.
Quantity in commerce: 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
Product codes and lots: Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1495-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1495-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-02
Z-1496-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-02
Z-1497-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-02

Product code DXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)