Ellipse Implantable Cardioverter Defibrillators (ICDs)
Medical device recall Z-2572-2014. Published in FDA’s Enforcement Report on Sep 10, 2014.
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 Sep 10, 2014. 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
- 51,492 units (27,396 units in US) 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?
An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. It may present as a vibratory patient notification and upon interrogation, a programmer or Merlin.net alert.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
51,492 units (27,396 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989…
Every code shown here, 2,000 characters
Serial Numbers: 1004962 1004963 1004964 1004965 1004966 1004967 1004968 1004969 1004970 1004971 1004972 1004973 1004974 1004975 1004976 1004977 1004978 1004979 1004980 1004981 1004982 1004983 1004984 1004985 1004986 1004987 1004988 1004989 1004990 1004991 1004992 1004993 1004994 1004995 1004996 1004997 1004998 1004999 1005000 1005001 1005002 1005003 1005004 1005005 1005006 1005007 1005008 1005009 1005010 1005011 1005139 1005140 1005141 1005142 1005143 1005144 1005145 1005146 1005147 1005148 1005149 1005150 1005151 1005152 1005153 1005154 1005155 1005156 1005157 1005158 1005159 1005160 1005161 1005162 1005163 1005164 1005165 1005166 1005167 1005168 1005169 1005170 1005171 1005172 1005173 1005174 1005175 1005176 1005177 1005178 1005179 1005180 1005181 1005182 1005183 1005184 1005185 1005186 1005187 1005188 1005311 1005312 1005313 1005314 1005315 1005316 1005317 1005318 1005319 1005320 1005321 1005322 1005323 1005324 1005325 1005326 1005327 1005328 1005329 1005330 1005331 1005332 1005333 1005334 1005335 1005336 1005337 1005338 1005339 1005340 1005341 1005342 1005343 1005344 1005345 1005346 1005347 1005348 1005349 1005350 1005351 1005352 1005353 1005354 1005355 1005356 1005357 1005358 1005359 1005360 1005734 1005735 1005736 1005737 1005739 1005740 1005741 1005742 1005743 1005744 1005745 1005746 1005747 1005748 1005749 1005750 1005751 1005752 1005753 1005754 1005755 1005756 1005757 1005758 1005759 1005761 1005762 1005763 1005764 1005766 1005767 1005768 1005769 1005770 1005771 1005772 1005773 1005774 1005775 1005776 1005777 1005778 1005779 1005780 1005781 1005782 1005783 1005784 1005785 1005786 1005787 1005788 1005790 1005791 1005792 1005793 1006090 1006091 1006092 1006093 1006094 1006095 1006096 1006097 1006098 1006099 1006100 1006101 1006102 1006103 1006104 1006105 1006106 1006107 1006108 1006109 1006110 1006111 1006112 1006113 1006114 1006115 1006116 1006117 1006118 1006119 1006120 1006121 1006122 1006123 1006124 1006125 1006126 1006127 1006128 1006129 1006130 1006131…
FDA’s list runs to 242,965 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.
Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
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.
The words say it went outside the United States too.
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 Aug 19, 2014.
- FDA classified it on Sep 3, 2014.
- FDA’s Enforcement Report published it on Sep 10, 2014.
- FDA terminated it on Oct 8, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- St Jude Medical Cardiac Rhythm Management Division, 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 242,965 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.