Recall archive / FDA device enforcement

Merlin PCS 3650 programmer Model 3330 software — FDA record Z-0964-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 10, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Merlin PCS 3650 programmer Model 3330 software
Reason: 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.
Classification: Class II
Recalling firm: St. Jude Medical, Cardiac Rhythm Management Division
Quantity: 30,069 devices with software
Agency-reported status: Ongoing
Source record identifier: Z-0964-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 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Label field

Details supplied by the agency

Lot, code or applicability

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 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17741 17747 17779 17791 17796 17801 17802 17803 17804 17808 17809 17818 17820 17821 17824 17826 17830 17831 17835 17837 17838 17839 17841 17842 17843 17847 17852 17853 17854 17858 17862 17864 17866 17867 17869 17870 17871 17872 17874 17875 17878 17880 17881 17883 17884 17885 17886 17887 17889 17891 17893 17894 17899 17900 17901 17902 17903 17904 17905 17910 17912 17914 17915 17916 17917 17918 17923 17924 17926 17927 17929 17930 17932 17933 17934 17935 17936 17940 17941 17946 17947 17952 17955 17957 17958 17960 17962 17963 17965 17966 17970 17971 17973 17980 17985 17991 17995 18000 18002 18004 18008 18012 18014 18015 18016 18017 18018 18019 18020 18021 18022 18025 18026 18027 18031 18032 18034 18036 18039 18041 18042 18045 18048 18049 18051 18052 18053 18054 18056 18058 18059 18060 18065 18068 18069 18070 18071 18073 18076 18078 18080 18082 18086 18087 18092 18096 18099 18101 18103 18104 18105 18109 18112 18119 18120 18121 18123 18132 18133 18134 18135 18143 18145 18152 18153 18155 18156 18157 18160 18161 18163 18164 1816...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 27, 2022
Recall initiation date: Mar 10, 2022
Center classification date: Apr 21, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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