Hearth Record

The Merlin PCS 3650 programmer

Medical device recall Z-0753-2025. Published in FDA’s Enforcement Report on Jan 1, 2025.

FDA’s own record, on accessdata.fda.gov

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 1, 2025. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

7295 programmers, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2…

Every code shown here, 2,000 characters

Programmer Model Number: 3650 UDI-DI code: 05414734509725 Software Version Number / Serial Numbers: 28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2 22212 28.0.1 REV 2 25022 28.0.1 REV 2 27371 28.0.1 REV 2 12044759 28.0.1 REV 2 12045223 28.0.1 REV 2 12052322 28.0.1 REV 2 12056132 28.0.1 REV 2 12060627 28.0.1 REV 2 12061640 28.0.1 REV 2 11628 28.0.1 REV 2 11891 28.0.1 REV 2 20861 28.0.1 REV 2 22163 28.0.1 REV 2 25164 28.0.1 REV 2 25942 28.0.1 REV 2 26189 28.0.1 REV 2 12040940 28.0.1 REV 2 12041991 28.0.1 REV 2 12045260 28.0.1 REV 2 12046359 28.0.1 REV 2 12051613 28.0.1 REV 2 12052588 28.0.1 REV 2 12055272 28.0.1 REV 2 12061523 28.0.1 REV 2 12073 28.0.1 REV 2 12386 28.0.1 REV 2 21011 28.0.1 REV 2 22744 28.0.1 REV 2 23629 28.0.1 REV 2 23881 28.0.1 REV 2 12048206 28.0.1 REV 2 12048470 28.0.1 REV 2 12138 28.0.1 REV 2 12330 28.0.1 REV 2 16714 28.0.1 REV 2 20209 28.0.1 REV 2 21538 28.0.1 REV 2 23327 28.0.1 REV 2 24046 28.0.1 REV 2 25837 28.0.1…

FDA’s list runs to 149,263 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

The states and territories these words name

45 states and territories.

Every one of them
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • North Carolina
  • North Dakota
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Puerto Rico
  • South Carolina
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Washington
  • Wisconsin
  • West Virginia

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

Is it still going on?

Ongoing, in FDA’s file.

“A recall which is currently in progress.”

openFDA, on “On-Going”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Nov 21, 2024.
  • FDA classified it on Dec 23, 2024.
  • FDA’s Enforcement Report published it on Jan 1, 2025.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Abbott Medical, of Sylmar, CA.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Letter.
Source:

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 149,263 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.
Source:

Hearth Record wrote these lines; the quotations are FDA’s.

Sources

  • 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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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