Merlin@home RF Remote Monitoring Transmitter
Medical device recall Z-2784-2015. Published in FDA’s Enforcement Report on Sep 23, 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 Sep 23, 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
- 259,214 transmitters (U.S. distribution) 23,604 (foreign distribution) 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?
Some devices exhibit backup VVI operation due to a backup reset.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD’s.
259,214 transmitters (U.S. distribution) 23,604 (foreign distribution), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model: EX1150 Serial #: 02902036 05103228 12200027 12200047 12200063 12200065 12200071 12200093 12200100 12200111 12200120 12200122 12200157 12200165 12200168 12200174 12200187 12200235 12200245 12200250 12200331 12200333 12200351 12200367…
Every code shown here, 1,995 characters
Model: EX1150 Serial #: 02902036 05103228 12200027 12200047 12200063 12200065 12200071 12200093 12200100 12200111 12200120 12200122 12200157 12200165 12200168 12200174 12200187 12200235 12200245 12200250 12200331 12200333 12200351 12200367 12200369 12200371 12200399 12200432 12200449 12200459 12200466 12200471 12200478 12200522 12200539 12200574 12200582 12200621 12200641 12200658 12200661 12200679 12200680 12200700 12200738 12200749 12200754 12200758 12200771 12200772 12200788 12200791 12200800 12200832 12200845 12200850 12200851 12200864 12200868 12200877 12200891 12200892 12200906 12200914 12200945 12200963 12200965 12200966 12200967 12200972 12200975 12200976 12200977 12200978 12200980 12200987 12200991 12200992 12200997 12200999 12201000 12201001 12201002 12201005 12201006 12201007 12201008 12201010 12201011 12201016 12201019 12201020 12201025 12201026 12201036 12201037 12201038 12201039 12201040 12201042 12201043 12201048 12201054 12201055 12201056 12201060 12201064 12201066 12201067 12201068 12201071 12201073 12201074 12201096 12201116 12201117 12201122 12201128 12201132 12201178 12201190 12201194 12201204 12201213 12201230 12201231 12201244 12201247 12201249 12201252 12201265 12201270 12201281 12201290 12201308 12201330 12201372 12201381 12201392 12201394 12201408 12201414 12201440 12201445 12201464 12201465 12201466 12201469 12201471 12201486 12201490 12201491 12201492 12201493 12201498 12201499 12201500 12201501 12201510 12201517 12201522 12201523 12201525 12201529 12201533 12201538 12201539 12201540 12201543 12201546 12201549 12201550 12201551 12201558 12201565 12201567 12201568 12201570 12201575 12201581 12201588 12201589 12201591 12201597 12201598 12201599 12201604 12201606 12201608 12201610 12201613 12201617 12201618 12201621 12201622 12201625 12201638 12201640 12201641 12201643 12201646 12201650 12201651 12201654 12201660 12201662 12201663 12201665 12201666 12201669 12201670 12201671 12201673 12201676 12201678 12201679 12201681 12201684 12201685…
FDA’s list runs to 1,568,796 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 foreign distribution to the following: Japan, France, Austria, Canada, Italy, Spain, Netherlands, South Africa, Great Britain, Australia, Sweden, Belgium, Finland, Germany, Portugal, Singapore, Norway, Poland, Ireland, Czech Republic. Denmark, Hong Kong, Saudi Arabia, Hungary, Switzerland.
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 Aug 18, 2015.
- FDA classified it on Sep 17, 2015.
- FDA’s Enforcement Report published it on Sep 23, 2015.
- FDA terminated it on May 19, 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 1,568,796 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.