Merlin PCS Programmer software
Medical device recall Z-0808-2020. Published in FDA’s Enforcement Report on Jan 22, 2020.
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 22, 2020. 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
- 2,906 impacted ICMs 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?
Devices inappropriately displayed a low battery indicator determined to be due to memory corruption.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
2,906 impacted ICMs, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Merlin PCS Programmer Software, V24.0.1 rev 1, UDI 05414734509725. Confirm Rx ICM, UDI 05415067027320, US serial numbers: 3161783 3165630 3169553 3172363 3175335 3175336 3175337 3175349 3175356 3175377 3175378 3175385 3175393 3175394…
Every code shown here, 1,994 characters
Merlin PCS Programmer Software, V24.0.1 rev 1, UDI 05414734509725. Confirm Rx ICM, UDI 05415067027320, US serial numbers: 3161783 3165630 3169553 3172363 3175335 3175336 3175337 3175349 3175356 3175377 3175378 3175385 3175393 3175394 3175395 3175399 3175402 3178901 3178907 3178909 3178916 3178919 3178921 3178930 3178937 3178943 3178945 3178946 3178951 3178954 3178962 3178969 3178974 3178981 3178995 3179005 3179024 3179103 3179123 3179149 3179177 3179199 3179260 3179443 3179452 3179520 3179533 3179539 3179542 3179543 3179570 3179583 3179589 3179595 3179603 3179609 3179850 3179851 3179921 3179929 3179953 3179965 3179972 3179988 3179991 3179997 3180019 3180030 3180038 3180309 3180326 3180333 3180411 3180420 3180421 3180424 3180578 3180604 3180607 3180608 3180617 3180661 3180675 3180679 3180692 3180695 3180704 3180969 3181038 3181066 3181067 3181168 3181171 3181174 3181175 3181199 3181203 3181217 3181226 3181233 3181246 3181248 3181267 3181494 3181655 3181683 3181688 3181742 3181744 3181745 3181776 3182193 3182217 3182228 3182229 3182230 3182248 3182262 3182300 3182523 3182585 3182594 3182617 3182632 3182858 3182863 3182885 3182890 3182939 3182950 3182965 3182972 3182989 3183002 3183003 3183005 3183043 3183105 3183112 3183270 3183281 3183294 3183307 3183321 3183332 3183638 3183715 3183739 3183777 3183782 3183821 3183842 3183847 3183915 3183961 3183979 3183987 3183988 3184008 3184076 3184142 3184160 3184192 3184225 3184238 3184239 3184251 3184259 3184297 3184307 3184321 3184389 3184407 3184415 3184431 3184441 3184442 3184443 3184453 3184469 3184471 3184476 3184487 3184490 3184495 3184510 3184529 3184531 3184547 3184552 3184555 3184565 3184582 3184599 3184656 3184667 3184690 3184700 3184717 3184726 3184727 3184813 3184862 3184887 3184892 3184946 3184953 3184968 3184970 3184972 3184987 3184994 3185013 3185026 3185032 3185078 3185362 3185456 3185821 3186402 3186416 3186422 3186425 3186456 3186463 3186472 3186502 3186505 3186512 3186518 3186527 3186585 3186804 3186807…
FDA’s list runs to 23,434 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. distribution. There was also government/military distribution. Countries of Canada, Aruba, Australia, Belgium, Brazil, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Luxembourg, Martinique, Netherlands, New Caledonia, New Zealand, Norway, Oman, Poland, Portugal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
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 Apr 13, 2018.
- FDA classified it on Jan 13, 2020.
- FDA’s Enforcement Report published it on Jan 22, 2020.
- FDA terminated it on Feb 10, 2021.
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: Other.
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 23,434 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.