CLASS II Device recall · Reported 25 Oct 2017 · FDA Enforcement Report

Merlin@Home recalled by St Jude Medical

St Jude Medical is recalling Merlin@Home. The recall was initiated on 28 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

Quantity recalled495,011 units (391,093 in US)

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-0033-2018
FDA event ID: 78093
Recalling firm: St Jude Medical, Sylmar, CA
Classification: Class II
Status: Terminated
Recall initiated: 28 Aug 2017
FDA classified: 19 Oct 2017
Reported: 25 Oct 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

28 Aug 2017	Recall initiated by company
19 Oct 2017	Classified by FDA	+52 days
25 Oct 2017	Published in enforcement report	+6 days

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

Reason for recall

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

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@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from the SJM implantable medical device (IMD) using RF telemetry. The data is then sent back to the Merlin.net Patient Care Network through a built-in modem or, alternatively, through a USB cellular adapter or a USB based Broadband Kit. The transmitted data enables clinicians to remotely monitor a patients IMD using a secure, encrypted, password-protected web site, thus reducing the number of in-clinic visits a patient needs to make to their physician. The transmitter monitors the patients device daily between scheduled follow-ups and can alert a clinician if it detects anything out of the norm.

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.

Which lots are affected?

Model EX1100 - GTIN 05414734504782 and Model EX1150 - GTIN 05414734404334

Where was it sold?

Worldwide Distribution

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

5 other products · FDA event 78093

This product is part of a recall event; the main page for the event is PM1226 Accent ST MRI SR RF and PM2222 Accent ST These low recalled.

Reported	Class	Recall	Company	Reason	Where
25 Oct 2017	CLASS II	PM1226 Accent ST MRI SR RF and PM2222 Accent ST These low recalled	St Jude Medical	Other	CA
25 Oct 2017	CLASS II	Pm1214 Nuance SR Rf recalled by St Jude Medical	St Jude Medical	Other	CA
25 Oct 2017	CLASS II	Merlin PCS 3650 Programmer recalled by St Jude Medical	St Jude Medical	Device Malfunction	CA
25 Oct 2017	CLASS II	PM 1260 Assurity + These low voltage recalled by St Jude Medical	St Jude Medical	Other	CA
25 Oct 2017	CLASS II	PM3544 Quadra Relieve and PM3562 Quadra Allure MP These low recalled	St Jude Medical	Other	CA

More recalls from St Jude Medical

All 47

Reported	Class	Recall	Company	Reason	Where
2 Apr 2025Device	CLASS II	CardioMEMS Heart Failure (HF) System that consist recalled	St. Jude Medical	Device Malfunction	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled	St. Jude Medical	Labeling Errors	Nationwide
29 Jan 2025Device	CLASS II	Merlin.net Patient Care Network recalled by St. Jude Medical	St. Jude Medical	Device Malfunction	13 states
24 Jul 2024Device	CLASS II	Agilis NxT Steerable Introducer recalled by St. Jude Medical	St. Jude Medical	Other	MN

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide