Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura…
Medical device recall Z-0115-2017. Published in FDA’s Enforcement Report on Nov 2, 2016.
- FDA Class I
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 Nov 2, 2016. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 204,785 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40, CD2231-40Q. Fortify ST DR, Model No. CD2241-40, CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q. Fortify Assura DR, Model No. CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
204,785 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial 607591 607592 607593 607594 607595 607596 607597 607598 607599 607600 607801 607802 607803 607804 607805 607806 607807 607808 607809 607810 607811 607812 607813 607814 607815 607816 607817 607818 607819 607820 607911 607912 607913…
Every code shown here, 1,995 characters
Serial 607591 607592 607593 607594 607595 607596 607597 607598 607599 607600 607801 607802 607803 607804 607805 607806 607807 607808 607809 607810 607811 607812 607813 607814 607815 607816 607817 607818 607819 607820 607911 607912 607913 607914 607915 607916 607917 607918 607919 607920 607921 607922 607923 607924 607925 607927 607928 607929 607930 608221 608222 608223 608224 608225 608226 608227 608228 608229 608230 608231 608232 608233 608234 608235 608236 608237 608238 608239 608240 608241 608242 608243 608244 608245 608246 608247 608248 608249 608250 608391 608392 608393 608394 608395 608396 608397 608398 608399 608400 608401 608402 608403 608404 608405 608406 608407 608408 608409 608410 608531 608532 608533 608534 608535 608536 608537 608538 608539 608540 608541 608542 608543 608544 608545 608546 608547 608548 608549 608550 608671 608672 608673 608674 608675 608676 608677 608678 608679 608680 608681 608682 608683 608684 608685 608686 608687 608688 608689 608690 608801 608802 608803 608804 608805 608806 608807 608808 608809 608810 608931 608932 608933 608935 608936 608937 608938 608939 608940 609071 609072 609073 609074 609075 609076 609078 609079 609080 609211 609212 609213 609214 609215 609217 609218 609219 609220 609351 609352 609353 609354 609355 609356 609357 609359 609360 609491 609492 609493 609494 609495 609496 609497 609498 609499 609500 609631 609632 609633 609635 609636 609637 609638 609639 609640 609771 609772 609773 609774 609775 609776 609777 609778 609779 609780 609911 609912 609913 609914 609915 609916 609917 609918 609919 609920 610051 610052 610053 610054 610055 610056 610057 610058 610059 610060 610261 610262 610263 610264 610265 610266 610267 610268 610269 610270 610411 610412 610413 610414 610415 610416 610417 610418 610419 610420 610571 610572 610573 610574 610575 610576 610577 610578 610579 610580 610711 610712 610713 610714 610715 610716 610717 610718 610720 610831 610832 610833 610834 610835 610836 610837 610838 610839 610840 610841…
FDA’s list runs to 929,076 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) and OUS
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 Oct 10, 2016.
- FDA classified it on Oct 21, 2016.
- FDA’s Enforcement Report published it on Nov 2, 2016.
- FDA terminated it on Sep 27, 2018.
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 929,076 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.