Merlin@home RF Remote Monitoring Transmitter
Medical device recall Z-0949-2015. Published in FDA’s Enforcement Report on Jan 21, 2015.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 21, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 257,456 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
257,456 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 25117181 25102957 25087732 25089415 12425463 25095596 25184682 12485839 25102906 25154103 25108918 25025302 12381443 25038455 25092708 12221170 25112136 25169594 25137228 25093615 25141686 25117458 25111604 25093649 25132546…
Every code shown here, 2,000 characters
Serial No. 25117181 25102957 25087732 25089415 12425463 25095596 25184682 12485839 25102906 25154103 25108918 25025302 12381443 25038455 25092708 12221170 25112136 25169594 25137228 25093615 25141686 25117458 25111604 25093649 25132546 25103939 25138550 25141540 25095698 25083041 12204274 12296007 25162338 25072003 25096827 25136903 25091678 25159164 25111804 25169442 25069921 12376794 25074237 25083876 25136384 25064617 12297599 25091439 25068034 25172146 25074154 25074190 25077852 25064811 12351513 25074801 25083477 12299937 25147716 25078787 25111411 12333835 25157659 25120763 25072304 25083123 25115365 25065318 12243413 25046069 12241670 12345709 12430239 25151639 25013443 25194240 12440854 12490301 12365721 12307572 25151201 25073392 25137086 25075167 12212657 25023097 12201701 12436413 25090438 25162500 25084216 25074239 25122865 25064060 25078847 25081883 25158300 25156425 25108020 25131891 25099682 25044455 25085127 12319299 25092986 25164788 25098858 25147437 12364659 25099680 12203035 25162977 25083707 25130451 12268716 25094478 25165470 25120979 25164423 12276169 25091327 25145089 25104189 12301806 25100142 25106010 25128023 25092563 25195551 25070168 25110871 25170212 25152734 12281122 25084095 25093341 25111669 12223150 25146260 25104240 25127894 25095164 12445642 25180558 25107557 12427343 25104066 25104328 25161760 25095487 25181602 25086980 25091757 25111404 25133109 25081866 25130031 12257160 25141361 25157193 25034502 25072710 25158675 25135806 25083282 12343703 25087602 25108628 25105366 25107021 12413483 25179653 25085187 25081389 25074423 25093890 25162600 25178781 25114683 25106319 25129538 25193362 25053910 25075363 25115915 25111660 25064973 25128626 25077342 25065734 25123206 25067886 12283584 12203167 25138027 25144330 25087518 25073838 25117539 25077085 25115324 25089748 25082678 25079660 25069243 25079693 12374934 25088330 25177898 25059625 25123678 12416707 25067402 25171055 12492779 25081472 25072928 25092856 25158331 25185572 12237767…
FDA’s list runs to 815,775 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 18, 2014.
- FDA classified it on Jan 9, 2015.
- FDA’s Enforcement Report published it on Jan 21, 2015.
- FDA terminated it on Mar 30, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Cardiac Rhythm Management Division, of Sylmar, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 815,775 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.