Quadra Assura, Sterile EO
Medical device recall Z-2324-2018. 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
- 72673 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?
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
72673, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1005250 1100829 1013442 1099070 1099529 1005562 1051389 1059113 1005929 1005557 1003819 1003806 1005547 1003851 1003825 1005545 1005936 1003843 1005964 1005252 1005934 1003833 1003852 1005931 1051430 1005260 1005963 1005949…
Every code shown here, 1,994 characters
Serial #: 1005250 1100829 1013442 1099070 1099529 1005562 1051389 1059113 1005929 1005557 1003819 1003806 1005547 1003851 1003825 1005545 1005936 1003843 1005964 1005252 1005934 1003833 1003852 1005931 1051430 1005260 1005963 1005949 1005950 1005256 1003835 1005946 1003815 1005954 1005966 1005958 1005264 1005941 1099534 1003820 1005262 1099517 1051417 1051415 1051408 1043032 1051434 1051428 1051411 1051423 1059110 1051387 1005553 1100826 1051410 1005267 1003844 1005544 1059097 1003816 1059111 1051394 1059105 1051398 1059112 1051385 1043026 1059108 1099349 1051422 1051407 1085829 1085833 1085837 1085831 1051309 1059118 1005566 1003803 1043020 1003805 1099341 1043023 1005953 1099523 1013447 1099051 1099057 1005944 1085835 1099528 1099060 1005940 1051402 1005259 1043021 1059117 1013443 1043027 1051319 1003846 1003826 1051397 1005935 1013449 1005565 1085832 1003807 1099532 1100823 1099065 1100816 1100822 1099518 1100828 1099513 1059099 1099046 1013445 1051432 1100825 1003841 1051314 1051435 1051405 1100824 1005939 1005942 1100832 1005559 1099068 1005265 1043033 1043035 1099066 1099342 1099522 1099537 1099067 1099054 1099535 1099056 1099347 1099344 1099053 1099367 1099061 1099527 1099357 1099063 1099356 1099359 1003827 1051421 1005961 1005970 1005546 1005955 1051404 1099050 1051412 1099049 1005567 1005261 1085840 1005972 1051409 1099055 1059107 1003828 1003840 1005945 1059098 1005948 1005554 1005975 1051384 1051386 1003834 1005933 1005974 1051391 1003839 1005969 1005960 1005569 1005971 1003845 1005951 1099512 1043019 1051424 1059114 1003814 1003829 1005543 1051420 1005978 1051315 1005568 1051419 1099360 1100817 1099525 1100821 1085830 1099519 1099538 1005977 1051426 1005266 1003847 1051383 1059100 1051392 1051401 1051317 1003804 1003831 1051390 1099516 1085841 1005976 1005928 1051431 1051433 1051316 1003808 1099352 1043022 1003849 1005255 1003809 1003836 1059120 1099365 1099361 1059115 1085836 1051418 1013444 1003813 1004102 1005604 1046479 1075198 1047116 1046532…
FDA’s list runs to 650,164 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 650,164 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.