Ellipse, Sterile EO
Medical device recall Z-2319-2018. 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
- 139351 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?
Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420
139351, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #: 1000285 1025921 1039639 1007290 1047328 1049523 1049131 1039582 1081611 1000297 1039626 1034690 1045516 1039595 1050351 1073423 1035840 1013891 841883 1029377 843705 1089977 1059411 1032549 1096245 1025909 1035863 1018923 1024055…
Every code shown here, 1,994 characters
Serial #: 1000285 1025921 1039639 1007290 1047328 1049523 1049131 1039582 1081611 1000297 1039626 1034690 1045516 1039595 1050351 1073423 1035840 1013891 841883 1029377 843705 1089977 1059411 1032549 1096245 1025909 1035863 1018923 1024055 1041061 1026435 1007262 1024035 1067727 1089972 1034708 1018919 1018937 1065395 1018938 1007284 1007265 1000279 1007291 1030532 1073365 1000413 835226 1018871 1001270 1061428 1007294 1007275 1007269 1018926 1039632 1054258 1041039 843699 1077179 1084892 1054257 1032552 1030542 1034687 1039636 1034692 1032545 1034700 1015064 1067733 1045537 1018887 1015066 1049528 1053202 1053203 1026433 1000406 1007295 1061425 1030530 1053208 1035841 1089979 1073368 1007278 1047919 1039624 1084889 1025898 1062889 1059398 1032535 1045494 1059402 1034683 1044801 1039591 1024022 1044804 1044794 1065388 1018893 1052064 1050347 1050355 1052067 1062895 1065392 1032527 1049518 1047302 1052056 1061415 1047905 1059419 1044786 1061410 1035866 1067716 1045531 1032542 1034686 1061412 1041043 1047322 1047910 1039631 1061408 1045518 1041062 1045543 1039617 1061407 1047937 1052065 1047940 1039615 1032550 1041046 1044797 1044802 1044782 1050336 1030531 1065378 1047900 1045530 1061417 1053206 1013856 1065386 1065376 1065375 1045549 1059407 1032539 1032546 1067741 1045512 1061400 1053201 1073343 1069484 1061403 1047325 843693 1018885 1024046 1015045 1024030 1023719 1041059 1052070 1045506 1047312 1018898 1062909 1044788 1062884 1062897 842419 841882 1026442 1045552 1077159 1062886 1001266 1045490 1013903 1045546 1045492 1039601 1034709 1007293 1045521 1047316 1053200 841878 1055476 1078879 1024031 1062910 1044783 1047327 1034673 1044785 1018890 1070535 1067731 1067709 1065396 1069489 1065384 1049521 1061404 1052071 1067738 1080902 1073342 1050357 1039609 1041040 1055474 1044820 1049530 1025902 1013897 1013890 1080899 1061390 1067722 1061405 1025899 1065398 1073393 1045544 1018944 1007276 1069504 1030538 1050340 1059408 1069498 1041050 1047908 1069500 1091245…
FDA’s list runs to 1,250,141 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 1,250,141 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.