Fortify Assura, Sterile EO
Medical device recall Z-2321-2018. 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
- 131093 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?
Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744
131093, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1045139 1035604 1045175 1050029 1035597 1062191 1064271 1064263 1064272 1032866 1064264 1086176 1115280 1018022 842863 1086165 1035596 842871 1062207 1062214 1044143 1062196 1050028 1050023 1035567 1044127 1045141 1062216 1045177…
Every code shown here, 2,000 characters
Serial #: 1045139 1035604 1045175 1050029 1035597 1062191 1064271 1064263 1064272 1032866 1064264 1086176 1115280 1018022 842863 1086165 1035596 842871 1062207 1062214 1044143 1062196 1050028 1050023 1035567 1044127 1045141 1062216 1045177 1032860 1086168 1062215 1064274 1062198 1106554 1035615 1044125 1062212 1086160 1051918 1045150 1045145 1018026 1086161 1044134 1032871 1026649 1045148 1045174 1035588 1044150 1062219 1045151 1050020 1101094 1026650 1086177 1026645 1062230 1062226 1045147 1026648 1050027 1026646 1051911 1062227 1062202 1064261 1086184 1036577 1064252 1086181 1018017 1045152 1064268 1062218 1064276 1018020 1062206 1018008 842865 1032861 1051913 1106553 1051919 1064259 1032857 1064257 1062208 1044153 842868 1064275 1051903 1064254 1045165 1086175 1051906 1045143 1051908 1044115 1044147 1044119 1032862 1062205 1062213 1051914 1044124 1064267 1044120 1045159 1045173 1045178 1045160 1045161 1045138 1051901 1044123 1051917 1044144 1035592 1018023 1062217 1045166 1064262 1035589 842862 1064269 1064270 1044133 1044146 1045155 1044145 1044142 1086171 1051905 1045146 1035610 1045158 1032869 1051909 1032867 1062220 1050030 1062201 1035566 1164258 1164256 1045163 1018011 1045168 1032872 1064273 1051902 1051907 1050022 1050021 1036579 1064256 1035562 1045172 1035577 1169595 1164257 1045170 1045144 1018007 1064258 1044139 1045137 1032868 1062204 1062211 1018025 1062229 1018010 839975 1044118 839970 1018021 1064249 1086164 1032870 1032859 1062221 1169594 1062225 1045176 1086182 1086180 1044138 1169597 1115279 1018005 842867 839968 1018013 1064266 1044140 1026642 1032864 1062192 1086179 1062194 1062224 1044122 1018009 1044129 1032858 1045156 1018014 1062209 1044136 839969 1062222 1051904 1032863 1086169 1086170 1109556 1035554 1044151 1106552 1044149 1035569 1018015 1044121 1035576 1044130 1062190 1045149 1086162 1086174 1064250 1045169 1045171 1045153 1044137 1050026 1018018 1062197 1062195 1062203 1051910 1032865 1044132 1062231 1062199 1032873 1032856 1044135…
FDA’s list runs to 1,175,807 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 1,175,807 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.