Merlin PCS 3650 programmer
Medical device recall Z-0964-2022. Published in FDA’s Enforcement Report on Apr 27, 2022.
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 Apr 27, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 30,069 devices with software 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?
Due to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable cardioverter and cardiac resynchronization therapy defibrillator devices, the programmer may continue to execute the Decrement Test instead of terminating the test and restoring the permanent programmed pacing parameters.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Merlin PCS 3650 programmer Model 3330 software
30,069 devices with software, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 3330 software Version: v25.X.X UDI: 05414734509725 System Affected Serial Numbers: 11339 11341 11344 11345 11346 11347 11348 11350 11351 11352 11353 11355 11358 11359 11360 11362 11364 11368 11372 11373 11374 11375 11379 11380 11382…
Every code shown here, 1,997 characters
Model 3330 software Version: v25.X.X UDI: 05414734509725 System Affected Serial Numbers: 11339 11341 11344 11345 11346 11347 11348 11350 11351 11352 11353 11355 11358 11359 11360 11362 11364 11368 11372 11373 11374 11375 11379 11380 11382 11385 11386 11387 11489 11491 11492 11494 11496 11497 11498 11499 11501 11502 11505 11507 11508 11509 11510 11512 11513 11516 11517 11518 11522 11524 11530 11534 11536 11537 11542 11545 11550 11552 11554 11555 11556 11557 11558 11561 11563 11564 11573 11574 11576 11577 11579 11582 11583 11587 11589 11590 11591 11593 11597 11598 11600 11602 11604 11605 11607 11611 11613 11614 11618 11619 11621 11622 11623 11624 11625 11626 11631 11633 11634 11637 11639 11642 11643 11647 11650 11652 11654 11655 11658 11661 11663 11664 11666 11667 11669 11671 11673 11675 11676 11677 11678 11679 11682 11683 11686 11687 11688 11689 11691 11694 11695 11696 11697 11700 11703 11704 11707 11708 11711 11712 11716 11718 11720 11721 11722 11724 11725 11726 11729 11730 11732 11733 11734 11735 11736 11745 11748 11749 11750 11751 11756 11757 11758 11759 11760 11762 11763 11765 11768 11769 11770 11771 11772 11773 11774 11778 11779 11780 11781 11782 11785 11788 11792 11793 11794 11796 11797 11801 11808 11809 11811 11812 11816 11818 11821 11822 11823 11824 11828 11829 11830 11832 11833 11836 11839 11840 11841 11842 11843 11844 11846 11847 11848 11849 11851 11853 11854 11855 11856 11858 11859 11861 11864 11866 11867 11868 11869 11870 11875 11877 11880 11881 11883 11884 11886 11889 11890 11894 11895 11896 11897 11899 11907 11909 11910 11913 11914 11915 11919 11922 11924 11925 11926 11927 11928 11929 11930 11933 11934 11936 11938 11940 11945 11946 11947 11949 11951 11952 11953 11954 11956 11957 11958 11960 11962 11971 11972 11975 11976 11977 11978 11980 11982 11983 11984 11985 11986 11989 11990 11993 11996 11997 11999 12001 12002 12004 12005 12007 12008 12009 12010 12011 12012 12013 12018 12019 12020 12022 12024 12025 12026 12027 12031 12032 12033 12034 12035 12038…
FDA’s list runs to 75,793 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 - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN. IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI and WY. The countries of Argentina, Australia, AUSTRIA, Bahrain, Bangladesh, BELGIUM, Brazil, Bulgaria, Canada, Chile, COLOMBIA, COSTA RICA, Cyprus, Czech republic, DENMARK, ECUADOR, Egypt, Estonia, Faroe Islands, FINLAND, FRANCE, French Guiana, French Polynesia, GERMANY, Greece, Greenland, Guadeloupe, HUNGARY, Iceland, India, IRELAND, ITALY, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, LITHUANIA, Luxembourg, Malaysia, Malta, Martinque, Mayotte, MEXICO, Nepal, NETHERLANDS, New Caledonia, New Zealand, NORWAY, Oman, Pakistan, Palestine, POLAND, PORTUGAL, Qatar, Reunion, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Srilanka, SWEDEN, SWITZERLAND, Thailand, UAE, and UNITED KINGDOM.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Mar 10, 2022.
- FDA classified it on Apr 21, 2022.
- FDA’s Enforcement Report published it on Apr 27, 2022.
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 75,793 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
-
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.