Abbott Medical Merlin@home Transmitter EX1100: Software Update Failure Risk
Abbott Medical recalls Merlin@home Transmitter EX1100 models with serial numbers listed. These devices may not update software after power interruptions during over-the-wire downloads, potentially causing monitoring issues.
Lower-risk 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.
Contact the company
What happened, in plain English
Abbott Medical is recalling Merlin@home Transmitter EX1100 models that may not update software after power interruptions during software downloads. This could lead to remote monitoring failures for heart patients. Read more at govinfonow.com/recall/53841-abbott-medical-merlin-home-transmitter-ex1100-software-update-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53841-abbott-medical-merlin-home-transmitter-ex1100-software-update-failure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0551-2025
Cite this page
“Abbott Medical Merlin@home Transmitter EX1100: Software Update Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53841-abbott-medical-merlin-home-transmitter-ex1100-software-update-failure-risk. Based on FDA recall #Z-0551-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2025%22&limit=1).
Why it’s dangerous
The transmitter may fail to update software after power interruptions during over-the-wire software downloads. This could prevent the device from transferring heart data to the monitoring system, potentially causing remote monitoring failures.
Who’s affected
Patients with implanted heart devices using Merlin@home Transmitter EX1100 models. Those with specific serial numbers listed in the recall are most at risk.
How to tell if you have this one
Check if your Merlin@home transmitter has the EX1100 model with serial numbers listed in the recall (e.g., 12600224, 12600307).
- Brand
Abbott Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Ongoing- Distribution
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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0551-2025 | 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.; 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 | 130 transmitters |
| Z-0552-2025 | Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability, the transmitter will retrieve full follow-up data or retrieve data for display on the Merlin.net" Patient Care Network (PCN). The MoD capability enables clinicians to do the following: . support remote care patients in emergency rooms and heart failure clinics . triage patients for in clinic follow-ups . support patients in a clinical setting with Merlin.net PCN; Model Number: EX1150 UDI-DI code: Pending Serial Numbers: Pending | Pending |
What to do — step by step
Check Serial Number
Identify if your transmitter has a serial number listed in the recall (e.g., 12600224, 12600307).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 28 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0551-2025 (October 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0551-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.