CLASS II ONGOING Device recall · Reported 10 Aug 2022 · FDA Enforcement Report

Merlin.net recalled by St. Jude Medical, Cardiac

St. Jude Medical, Cardiac Rhythm Management Division is recalling Merlin.net, distributed in 44 states. The recall was initiated on 17 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Merlin.net" v11.7 (MN5000 v7.8.rev6).; UDI/DI 05414734509732

Quantity recalledunknown

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1497-2022
FDA event ID: 90530
Recalling firm: St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Jun 2022
FDA classified: 2 Aug 2022
Reported: 10 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

17 Jun 2022	Recall initiated by company
2 Aug 2022	Classified by FDA	+46 days
10 Aug 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Merlin.net model MN5000 Software

Where it was distributed

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

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri

Questions about this recall

Why was it recalled?

Which lots are affected?

Software Merlin.net" v11.7 (MN5000 v7.8.rev6).; UDI/DI 05414734509732

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 90530

This product is part of a recall event; the main page for the event is Merlin MER37000 programmer recalled by St. Jude Medical, Cardiac.

Reported	Class	Recall	Company	Reason	Where
10 Aug 2022	CLASS II	Merlin MER37000 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
10 Aug 2022	CLASS II	Merlin PCS 3650 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states

More recalls from St. Jude Medical, Cardiac Rhythm Management Division

All 10

Reported	Class	Recall	Company	Reason	Where
10 Aug 2022Device	CLASS II	Merlin PCS 3650 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
10 Aug 2022Device	CLASS II	Merlin MER37000 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	44 states
27 Apr 2022Device	CLASS II	Gallant VR Implantable Cardioverter Defibrillator recalled	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	Merlin MER3700 programmer recalled by St. Jude Medical, Cardiac	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide
27 Apr 2022Device	CLASS II	Gallant DR Implantable Cardioverter Defibrillator recalled	St. Jude Medical, Cardiac Rhythm Management Division	Device Malfunction	Nationwide

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