CLASS III ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Merlin@home Transmitter recalled by Abbott Medical

Abbott Medical is recalling Merlin@home Transmitter, distributed nationwide in the US. The recall was initiated on 1 Oct 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel Number: EX1100 UDI-DI code: Pending Serial Numbers: 12600224 12600307 12600895 12600974 12601074 12601156 12601169 12602176 12602216 12602464 12602491 12604265 12604852 12606254 12606332 12606531 12606550 12606551 12606587 12606785 12606814 12607289 12607557 12608093 12608346 12608623 12608678 12608758 12608819 12609094 12609148 12609819 12609919 12610472 12610550 12611493 12611733 12611975 12612409 12612417 12612541 12612929 12613146 12613636 12617342 12617350 12617583 12617821 12618054 12618130 12618726 12618782 12619218 12619405 12619515 12619825 12619827 12620745 12621171 12622233 12622283 12622473 12623904 12625575 12625701 12625874 12628403 12628624 12628626 12634096 12634120 12634141 12634152 12634208 12635184 12635287 12636062 12636067 12636127 12636195 12638900 12639020 12640950 12641103 12641819 12643036 12643543 12643551 12643589 12643621 12643623 12643640 12643744 12643781 12643792 12647278 12647327 12647343 12647350 12647621 12647781 12647787 12647789 12647904 12647923 12647939 12647940 12648513 12648520 12648589 12648611 12648704 12648839 12649443 12649481 12649517 12650938 12651018 12651022 12651051 12651056 12651073 12651198 12651419 12651476 12651597 12652036 12652060 12652070 12652076

Quantity recalled130 transmitters

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-0551-2025
FDA event ID: 95557
Recalling firm: Abbott Medical, Sylmar, CA
Classification: Class III
Status: Ongoing
Recall initiated: 1 Oct 2024
FDA classified: 26 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

1 Oct 2024	Recall initiated by company
26 Nov 2024	Classified by FDA	+56 days
4 Dec 2024	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

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

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 Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (EX1150 Model) to read device data and transmitting to the Merlin.net PCN server.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of ALABAMA, ALASKA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, ILLINOIS, INDIANA, KENTUCKY, MICHIGAN, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEW JERSEY, NEW YORK, NORTH CAROLINA, OHIO, OREGON, PENNSYLVANIA, SOUTH CAROLINA, TENNESSEE, TEXAS, VIRGINIA, WASHINGTON and WISCONSIN. The country of Australia.

Nationwide Alaska Alabama Arkansas California Colorado Connecticut District of Columbia Florida Georgia Illinois Indiana Kentucky Michigan Missouri Mississippi Montana North Carolina Nebraska New Jersey New York

Questions about this recall

Why was it recalled?

Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.

Which lots are affected?

Model Number: EX1100 UDI-DI code: Pending Serial Numbers: 12600224 12600307 12600895 12600974 12601074 12601156 12601169 12602176 12602216 12602464 12602491 12604265 12604852 12606254 12606332 12606531 12606550 12606551 12606587 12606785 12606814 12607289 12607557 12608093 12608346 12608623 12608678 12608758 12608819 12609094 12609148 12609819 12609919 12610472 12610550 12611493 12611733 12611975 12612409 12612417 12612541 12612929 12613146 12613636 12617342 12617350 12617583 12617821 12618054 12618130 12618726 12618782 12619218 12619405 12619515 12619825 12619827 12620745 12621171 12622233 12622283 12622473 12623904 12625575 12625701 12625874 12628403 12628624 12628626 12634096 12634120 12634141 12634152 12634208 12635184 12635287 12636062 12636067 12636127 12636195 12638900 12639020 12640950 12641103 12641819 12643036 12643543 12643551 12643589 12643621 12643623 12643640 12643744 12643781 12643792 12647278 12647327 12647343 12647350 12647621 12647781 12647787 12647789 12647904 12647923 12647939 12647940 12648513 12648520 12648589 12648611 12648704 12648839 12649443 12649481 12649517 12650938 12651018 12651022 12651051 12651056 12651073 12651198 12651419 12651476 12651597 12652036 12652060 12652070 12652076

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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

1 other product · FDA event 95557

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024	CLASS III	Merlin@home with the MerlinOnDemand capability Transmitter recalled	Abbott Medical	Device Malfunction	Nationwide

More recalls from Abbott Medical

All 33

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17 Jun 2026Device	CLASS II	Merlin" Patient Care System (PCS) recalled by Abbott Medical	Abbott Medical	Device Malfunction	Nationwide
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23 Apr 2025Device	CLASS II	Aveir DR Leadless Pacemaker (LP) Ventricular Device recalled	Abbott Medical	Temperature Abuse	Nationwide
4 Dec 2024Device	CLASS III	Merlin@home with the MerlinOnDemand capability Transmitter recalled	Abbott Medical	Device Malfunction	Nationwide
27 Nov 2024Device	CLASS II	Abbot Navitor, Vision Technology recalled by Abbott Medical	Abbott Medical	Device Malfunction	NY

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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