Promote Quadra, Sterile EO
Medical device recall Z-2323-2018. Published in FDA’s Enforcement Report on Jul 4, 2018.
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 Jul 4, 2018. 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
- 10425 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?
The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against unauthorized device access. For older generation devices not capable of accepting the firmware, the firm is advising customers of the option to permanently disable the RF communication capability in these devices.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
10425, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 585796 584135 584051 584008 584133 583946 583999 583991 584136 583996 583982 583943 584078 583980 584005 584007 584106 583989 584128…
Every code shown here, 1,994 characters
Serial #: 1062415 584948 584973 844882 1059669 585788 844881 585793 585797 844884 585785 585777 1059667 585796 584135 584051 584008 584133 583946 583999 583991 584136 583996 583982 583943 584078 583980 584005 584007 584106 583989 584128 583950 584028 584060 584115 583968 584064 584067 584069 584029 584077 584024 584116 584058 584044 584111 583930 583964 584065 583994 584032 583966 583990 583979 584062 568379 583959 584056 568359 584019 584015 584126 584014 583978 583975 584038 584050 584013 584049 583954 584127 584031 584080 584119 568348 584071 584070 584021 584000 583957 584122 584083 583987 584081 584035 583976 584072 583997 583985 584040 583963 584017 584054 584026 584002 568380 584068 584034 583972 584043 584023 583981 584125 584001 585635 585143 585420 585127 585405 585289 585400 585422 585379 585370 585442 585319 585357 585129 585423 585414 585445 585435 585428 585099 585415 585438 585446 585444 585140 585436 585409 585365 585408 585705 585608 585696 585724 585715 585760 585732 585708 585629 585698 585693 585699 585697 585734 585725 585686 585681 585719 585710 585721 585740 585443 585694 585677 585746 585722 585680 585763 585712 585703 585727 585690 585700 585632 585729 585702 585747 585748 585678 585354 585348 585388 585744 585753 585146 585689 585711 585687 585695 585728 585749 585723 585758 585755 585726 585720 585688 585434 585752 585278 585733 585757 585761 585714 585736 585684 585739 585704 585387 585685 585691 585759 585682 585619 585706 585756 585741 585738 585750 585754 585590 584463 584461 584431 584489 584330 584521 584353 584368 584446 584508 584090 584495 584356 584170 583948 584483 584412 584476 584418 568405 584454 584473 584464 584513 584487 584444 584434 584465 584422 568370 568483 584171 584459 584485 585631 585742 585717 585764 585766 585701 585582 585120 585299 585567 585605 585612 585574 585595 585560 585094 585576 585628 585585 585583 585617 585251 585075 585573 585623 585633 585571 585566 585360 585578 585614 585613 585286 585133…
FDA’s list runs to 76,534 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.
U.S. Nationwide distribution
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.
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 16, 2018.
- FDA classified it on Jun 28, 2018.
- FDA’s Enforcement Report published it on Jul 4, 2018.
- FDA terminated it on Mar 8, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Inc., 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 76,534 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.