Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model…
Medical device recall Z-0116-2017. 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?
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. 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 591053 591054 591055 591056 591057 591058 591059 591060 591061 591062 591063 591064 591065 591066 591067 591068 591069 591070 591071 591072 591132 591133 591134 591135 591136 591137 591138 591139 591140 591141 591142 591143 591144…
Every code shown here, 1,995 characters
Serial 591053 591054 591055 591056 591057 591058 591059 591060 591061 591062 591063 591064 591065 591066 591067 591068 591069 591070 591071 591072 591132 591133 591134 591135 591136 591137 591138 591139 591140 591141 591142 591143 591144 591145 591146 591147 591148 591149 591150 591151 591152 591153 591154 591155 591156 591157 591158 591159 591160 591161 591162 591163 591164 591235 591236 591237 591238 591239 591240 591241 591242 591243 591244 591245 591246 591247 591248 591249 591250 591251 591252 591253 591254 591255 591256 591257 591258 591259 591260 591261 591262 591263 591264 591265 591266 591267 591268 591269 591270 591271 591272 591273 591274 591275 591276 591277 591278 591338 591339 591340 591341 591342 591343 591344 591345 591346 591347 591348 591349 591350 591351 591352 591353 591354 591355 591356 591357 591358 591359 591360 591361 591362 591363 591364 591365 591366 591367 591368 591369 591370 591371 591372 591373 591374 591375 591376 591377 591378 591649 591650 591651 591652 591653 591654 591655 591656 591657 591658 591659 591660 591661 591662 591663 591664 591665 591666 591667 591668 591669 591670 591671 591672 591673 591674 591675 591676 591677 591678 591679 591680 591681 591682 591683 591684 591685 591686 591687 591688 591689 591690 591691 591692 591693 591694 591695 591696 591697 591698 592586 592587 592588 592589 592590 592591 592592 592593 592594 592595 592596 592597 592598 592599 592600 592601 592602 592603 592604 592605 592606 592607 592608 592609 592610 592611 592612 592613 592614 592615 592616 592617 592618 592619 592620 592621 592622 592623 592624 592625 592726 592727 592728 592729 592730 592731 592732 592733 592734 592735 592736 592737 592738 592739 592740 592741 592742 592743 592744 592745 592746 592747 592748 592749 592750 592751 592752 592753 592754 592755 592756 592757 592758 592759 592760 592761 592762 592763 592764 592765 592906 592907 592908 592909 592910 592911 592912 592913 592914 592915 592916 592917 592918 592919 592920 592921…
FDA’s list runs to 748,730 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 748,730 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
-
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.